Methods, instruments and devices for extragastric reduction of stomach volume

ABSTRACT

Methods, instruments and systems are provided for separating opposite walls of the stomach by extragastric application of suction. Plication of the stomach can be performed between the separated walls after which the separate walls are brought back toward one another. In another aspect, methods, instruments, devices and systems are provided for reducing the effective volume of a stomach by performing one or more extragastric plications of the stomach.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional Application No.61/584,289, filed Jan. 8, 2012 and titled “Methods, Instruments andDevices for Extragastric Reduction of Stomach Tissue” and is acontinuation-in-part of U.S. patent application Ser. No. 13/439,059,filed Apr. 4, 2012 and titled “Methods, Instruments and Devices forExtragastric Reduction of Stomach Volume,” now U.S. Pat. No. 8,382,775,which applications are hereby incorporated herein, in their entirety, byreference thereto.

BACKGROUND OF THE INVENTION

Obesity has become a major health concern, both nationally andinternationally. The National Center for Health Statistics (NCHS)estimates that over 120 million Americans are overweight, includingabout 56% of the adult population. Of these, about 52 million areconsidered obese, as measured by a body mass index (BMI) of 30% orgreater. In Europe, an estimated 77 million people are obese, asmeasured by the same standard. This problem is not limited to westernnations, as many developing countries are reported to have obesity ratesover 75% of the adult population.

Co-morbidities that are associated with obesity include, but are notlimited to type II Diabetes, high blood pressure, sleep apnea, strokeand arthritis, the symptoms of which often tend to be lessened oralleviated upon loss of weight by a person so affected.

One current treatment methodology for treatment of obesity is calledgastric bypass surgery and another is referred to as gastric banding(one of these techniques uses a device referred to as the LAPBAND™).These procedures are limited to only those patients with a BMI over 40(or over 35, with co-morbidities present).

Gastric bypass procedures incur a great deal of morbidity and create amalabsorptive state in the patient by bypassing a large portion of theintestines. Serious side effects, such as liver failure have beenassociated with this procedure, as well as chronic diarrhea. Anothersurgical procedure that has a high degree of morbidity associated withit is known as the “Gastric Bypass Roux-en-Y” procedure. This procedurereduces the capacity of the stomach by creating a smaller stomach pouch.The small space holds only about one ounce of fluid. A tiny stomachoutlet is also surgically created to slow the speed at which food leavesthe stomach. Staples are used to create a small (15 to 20 cc) stomachpouch, with the rest of the stomach being stapled completely shut anddivided from the stomach pouch. The small intestine is divided justbeyond the duodenum, brought up, and connected to the newly formedstomach pouch. In addition to the considerable morbidity associated withthis procedure, other disadvantages include “dumping syndrome”, wherestomach contents are literally “dumped” rapidly into the small intestinewhich may lead to nausea, weakness, sweating, faintness, and diarrhea;hernias resulting from the surgery; gallstones; leakage of theconnection between the pouch and the intestine; stretching of the pouchthat was formed; nutritional deficiencies; and adverse effects,including but not limited to erosion of the mucosa caused by staplingentirely through the walls of the stomach.

The LAPBAND™ is a band that, when placed, encircles the fundus-cardiajunction and is inflatable to constrict the same. It does not reduce thevolume of the stomach, but rather restricts passage of food into thestomach, the theory being that the patient will feel satiety with a muchless volume of food than previously. Although the LAPBAND™ procedure isless invasive than a gastric bypass procedure, it also typicallyachieves less weight loss. Further, it is not a simple procedure andrequires a substantial amount of training by a surgeon to becomeproficient in performing the procedure. Also, a substantial amount ofdissecting and suturing is required because the pathway by which theband is introduced is not an existing pathway, and must be establishedby dissection. Great care is required to avoid blood vessels and nervesthat may be in the intended pathway to be created by the dissection.Another potential problem is that of slipping or other displacement ofthe band from its intended location which often requires anotherprocedure to reposition, replace or altogether remove the band. Afterplacing the band around the fundus-cardia junction, the ends of the bandmust be connected together and then it must be cinched down into place.Additionally, complications such as erosion at the fundus-cardiajunction, slippage of the band from its intended location,nausea/vomiting, gastroesophageal reflux, dysphagia and lack ofeffectiveness in causing weight loss have been reported.

Intra-gastric balloons have also been placed, in an attempt to fill aportion of the volume in the stomach, with the theory being that it willthen require less food than previously, to give the patient a sensationof fullness or satiety. This procedure involves delivery of a balloon(typically, trans-orally) to the interior of the stomach and inflationof the balloon to take up a portion of the volume inside the stomach.However, intra-gastric balloons may also lead to complications such asobstruction, vomiting and/or mucosal erosion of the inner lining of thestomach. The balloon can break down over extended exposure to thestomach's acids, and in some cases, after breaking down, the balloontranslated through the intestines and caused a bowel obstruction.

Gastrointestinal sleeves have been implanted to line the stomach and/ora portion of the small intestines to reduce the absorptive capabilitiesof the small intestine and/or to reduce the volume in the stomach, byreducing the available volume to the tubular structure of the graftrunning therethrough. Although weight loss may be effective while thesetypes of devices are properly functioning, there are complications withanchoring the device within the stomach/GI tract, as the stomach and GItract function to break down things that enter into them and tomove/transport them through. Accordingly, the integrity of the anchoringof the device, as well as the device itself may be compromised over timeby the acids and actions of the stomach and GI tract.

A sleeve gastrectomy is an operation in which the left side of thestomach is surgically removed. This results in a much reduced stomachwhich is substantially tubular and may take on the shape of a banana.This procedure is associated with a high degree of morbidity, as a largeportion of the stomach is surgically removed. Additionally, there arerisks of complications such as dehiscence of the staple line where thestaples are installed to close the surgical incisions where the portionof the stomach was removed. Further, the procedure is not reversible.

In the laparoscopic duodenal switch, the size of the stomach is reducedin similar manner to that performed in a sleeve gastrectomy.Additionally, approximately half of the small intestine is bypassed andthe stomach is re-connected to the shortened small intestine. Thisprocedure suffers from the same complications as the sleeve gastrectomy,and even greater morbidity is associated with this procedure due to theadditional intestinal bypass that needs to be performed. Still further,complications associated with malabsorption may also present themselves.

An inflatable gastric device is disclosed in U.S. Pat. No. 4,246,893, inwhich a balloon is inserted anteriorly of the stomach and posteriorly ofthe left lobe of the liver. The balloon is then inflated to compress thestomach so that it fills with less food that would ordinarily bepossible. Not only does this device compress the stomach, but it alsocompresses the liver, as seen in FIG. 5 of the patent, which may causecomplications with the liver function. Additionally, the balloon issimply placed into this location, and there is no assurance that it willnot migrate and lose its effectiveness in compressing the stomach to thedegree intended. Still further, the balloon is of a simple sphericaldesign, and, as such, extends pressure outwardly in all directions, 360degrees in all planes. Accordingly, the liver is compressed just as muchas the stomach is. Also, the compression forces against the stomach arenot ideal, as the spherical balloon conformation does not match theconformation of the expanding stomach. The stomach is not spherical whenexpanded, or concave with a constant radius of curvature, but expandsinto a designated space that allows the fundus to expand preferentiallymore than other parts of the stomach.

U.S. Pat. No. 7,717,843 and U.S. Patent Application Publication No.2005/0261712 to Balbierz et al. describe capturing a device against theouter surface of the stomach wall to form a restriction that appears tofunction similarly to the restriction imposed by the LAPBAND™. Theanchoring of the devices disclosed relies upon placement of featuresagainst the internal wall of the stomach to form an interlock with thedevice which is placed against the external wall of the stomach. Theplacement of features against the internal wall runs the risk of erosionof the mucosa, digestion and/or displacement of the features against theinternal wall, and other risks associated with implanting within thestomach, as described above.

U.S. Pat. No. 6,981,978 to Gannoe discloses devices for reducing theinternal cavity of the stomach to a much smaller volume, which may beused to carry out a bypass procedure. Stapling is employed to isolatethe smaller volume in the stomach, and thus the same potentialdisadvantages are present as with other stapling procedures used tostaple the stomach together in mucosa to mucosa contact as describedherein.

U.S. Pat. No. 6,186,149 to Pacella et al. describes an occluder devicethat can be used as a dietary control device (see FIG. 8C). The occluderdevice is placed against the wall of the stomach and inflated to pressinwardly on the stomach wall. A frame is wrapped around the stomach walland is inflated to press against the stomach wall. However, there is nodisclosure of how the frame might be adjusted to maintain a positionrelative to the stomach wall as the size of the stomach varies.

Gastric reduction techniques have been attempted, such as by insertinginstruments trans-orally and reducing the volume of the stomach bystapling portions of it together. However, this technique also runsrisks such as those described above, such as erosion of the mucosa.

Techniques referred to as gastric pacing endeavor to use electricalstimulation to simulate the normal feedback mechanisms of a patient thatsignal the brain that the patient is full, or satiated. While thesetechniques are less invasive than some of the other existing treatments,statistics to date have shown that the amount of weight lost by usingsuch techniques is less than satisfactory.

Currently marketed drugs for weight loss, such as XENICAL®, MERIDIA® andPhen fen have largely failed, due to unacceptable side effects andcomplications, and sometimes to an ineffective amount of weight loss.Other drugs that are on the horizon include ACCOMPLIA® and SYMLIN®, butthese are, as yet, unproven.

The risk and invasiveness factors of currently available surgeries areoften too great for a patient to accept to undergo surgical treatmentfor his/her obesity. Accordingly, there is a need for less invasive, yeteffective surgical treatment procedures for morbidly obese patients(patients having a BMI of 35 or greater). Also, since the currentsurgical procedures are currently indicated only for those patientshaving a BMI of 40 or greater, or 35 or greater when co-morbidities arepresent, it would be desirable to provide a surgical procedure thatwould be available for slightly less obese patients, e.g., patientshaving a BMI of 30 to 35 who are not indicated for the currentlyavailable surgical procedures. It would further be desirable to providea surgical procedure that would be indicated for obese patients having aBMI in the range of 30-35, as well as for more obese patients.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, a method fordecreasing the effective volume of a patient's stomach is provided thatincludes: contacting and engaging a length of a first end effector to anexternal surface of the stomach on a first side of the stomach;contacting and engaging a length of a second end effector to an externalsurface of the stomach on a second side of the stomach opposite thefirst side; separating the first and second end effectors and oppositesides of the stomach; moving a portion of the stomach through a gapformed by separating the first and second end effectors; and moving thefirst and second end effectors and the opposite sides of the stomachtoward one another to contact folded tissue surfaces adjacent thesurfaces engaged by the end effectors into contact with one another.

In at least one embodiment, the method includes attaching the foldedtissue surfaces together in serosa-to-serosa contact.

In at least one embodiment, the method includes rotating the first andsecond end effectors to rotate the stomach so that the portion of thestomach is superior to the gap; wherein moving a portion of the stomachthrough a gap is assisted by gravity as the portion is dropped throughthe gap between the first and second end effectors.

In at least one embodiment, the method includes counter-rotating the endeffectors after moving the first and second end effectors toward oneanother to contact folded tissue surfaces adjacent the surfaces engagedby the end effectors into contact with one another.

In at least one embodiment, the rotating comprises rotating by aboutninety degrees.

In at least one embodiment, the counter-rotating is an amount aboutequal to the rotation.

In at least one embodiment, the engaging is performed by applyingsuction to the surfaces through the end effectors.

In at least one embodiment, the first and second end effectors aredistal end portions of a clamping tool.

In at least one embodiment, attaching the folded tissue surfacestogether comprises driving sutures from one of the end effectors throughthe folded tissues and into connection with anchors on the other of theend effectors.

In at least one embodiment, the method includes placing a layer ofmaterial adjacent to or between a location where the folded tissues areconnected together to discourage the stomach from herniating out betweensuture connections.

In at least one embodiment, the layer of material discourages ingrowthof tissue therein.

In at least one embodiment, the method includes temporarily installing abougie in the stomach prior to moving a portion of the stomach, toprovide a guide for the resulting size of the lumen through the stomach.

In at least one embodiment, at least a portion of the bougie has clearwalls and the bougie is configured to receive a flexible endoscopetherein, the method further comprising inserting the flexible endoscopeand visualizing within the stomach through the bougie.

In at least one embodiment, the method includes inserting an expandableimplant in a plication formed by moving a portion of the stomach througha gap formed by separating the first and second end effectors; andwherein moving the first and second end effectors toward one another tocontact folded tissue surfaces adjacent the surfaces engaged by the endeffectors into contact with one another surrounds the expandableimplant.

In at least one embodiment, the method includes placing a layer ofmaterial adjacent to or between a location where the folded tissues areconnected together to discourage the stomach from herniating out betweenconnections.

In at least one embodiment, the layer of material extends from and isconnected to or integral with the expandable implant.

In at least one embodiment, the layer of material discourages ingrowthof tissue therein.

In at least one embodiment, attaching the folded tissue surfacestogether in serosa-to-serosa contact comprises simultaneously driving aplurality of attachment members through the folded tissue surfaces,wherein the attachment members are configured along a length directionrelative to the end effectors.

In another aspect of the present invention, an instrument for use inmodifying a patient's stomach by operating on the stomach extragastrically to decrease the effective volume of the patient's stomach isprovided that includes: a first elongate end effector at a distal endportion of the instrument, the first elongate end effector having afirst operational surface configured to contact an external surface ofthe patient's stomach; a second elongate end effector at a distal endportion of the instrument, the second elongate end effector having asecond operational surface configured to contact an external surface ofthe patient's stomach on a location opposite of where the first elongateend effector is configured to contact the external surface of thestomach, and wherein the second operational surface opposes the firstoperational surface; a first plurality of suction ports extending alonga length of the first elongate end effector and configured to deliversuction to the external surface of the stomach to engage the firstelongate end effector therewith; and a second plurality of suction portsextending along a length of the second elongate end effector andconfigured to deliver suction to the external surface of the stomach toengage the second elongate end effector therewith.

In at least one embodiment, the first and second pluralities of suctionports are configured to apply suction in an amount sufficient to pullopposite walls of the stomach apart when the first and second elongateend effectors are engaged therewith and the first and second elongateend effectors are moved apart from one another, and wherein the oppositewalls are pulled apart without losing engagement of the first and secondelongate end effectors therewith.

In at least one embodiment, the first elongate end effector has a firstdistal end portion and a first proximal end portion and the secondelongate end effector has a second distal end portion and a secondproximal end portion, wherein the first and second elongate endeffectors are pivotally connected at the first and second proximal endportions, and wherein the first and second distal end portions includefirst and second free distal ends, respectively.

In at least one embodiment, the instrument further includes means fordriving a plurality of connectors from the first elongate end effector,through stomach tissue and to the second elongate end effector.

In at least one embodiment, the instrument further includes means forfixing the connectors to maintain a plication in the stomach.

In at least one embodiment, the suction ports are elongated.

In at least one embodiment, the instrument further includes an elongateshaft extending proximally from proximal end portions of the first andsecond elongate members.

In at least one embodiment, the instrument further includes an actuatorlocated on a handle at a proximal end portion of the elongate shaft, theactuator being configured to actuate at least one function of theelongate end effectors.

In at least one embodiment, the instrument further includes a pluralityof suture drivers extending along a length of the first elongate endeffector.

In at least one embodiment, the instrument further includes a pluralityof suture anchors extending along a length of the second elongate endeffector and opposing the plurality of suture drivers, respectively.

In at least one embodiment, the instrument further includes a pluralityof sutures releasably engaged with the plurality of suture drivers,respectively.

In at least one embodiment, each suture extends through a suture lockreleasably provided on the first elongate end effector.

In at least one embodiment, each suture comprises an anchor mate mountedon a distal end portion thereof, the anchor mate being configured toengage with and connect to the anchor.

In at least one embodiment, the instrument is further provided with alayer of material configured to be placed adjacent to or betweenlocations where the connectors from the first elongate end effector areconfigured to pass through the stomach tissue and to the second elongateend effector.

In at least one embodiment, the layer of material discourages ingrowthof tissue therein.

In at least one embodiment, an expandable implant is provided that isconfigured to be implanted in a plication created by the instrument.

In at least one embodiment, a bougie is provided that is configured tobe temporarily placed in the stomach prior to forming a plication withthe instrument.

In at least one embodiment, at least a portion of the bougie has clearwalls and the bougie is configured to receive a flexible endoscopetherein.

In at least one embodiment, a flexible endoscope is provided that isinsertable into the bougie.

In another aspect of the present invention, a system for use inmodifying a patient's stomach by operating on the stomach extragastrically to decrease the effective volume of the patient's stomach isprovided that includes: an engagement instrument comprising: a firstelongate end effector at a distal end portion of the engagementinstrument, the first elongate end effector having a first operationalsurface configured to contact an external surface of the patient'sstomach; a second elongate end effector at a distal end portion of theengagement instrument, the second elongate end effector having a secondoperational surface configured to contact an external surface of thepatient's stomach on a location opposite of where the first elongate endeffector is configured to contact the external surface of the stomach,and wherein the second operational surface opposes the first operationalsurface; a first plurality of suction ports extending along a length ofthe first elongate end effector and configured to deliver suction to theexternal surface of the stomach to engage the first elongate endeffector therewith; and a second plurality of suction ports extendingalong a length of the second elongate end effector and configured todeliver suction to the external surface of the stomach to engage thesecond elongate end effector therewith; and a stitching instrumentcomprising: a third elongate end effector at a distal end portion of thestitching instrument, the third elongate end effector having a thirdoperational surface configured to contact an external surface of thepatient's stomach; a fourth elongate end effector at a distal endportion of the stitching instrument, the fourth elongate end effectorhaving a fourth operational surface configured to contact an externalsurface of the patient's stomach on a location opposite of where thethird elongate end effector is configured to contact the externalsurface of the stomach, and wherein the fourth operational surfaceopposes the third operational surface; a plurality of suture driversextending along a length of the third elongate end effector; and aplurality of suture anchors extending along a length of the fourthelongate end effector and opposing the plurality of suture drivers,respectively.

In at least one embodiment, the first and second pluralities of suctionports are configured to apply suction in an amount sufficient to pullopposite walls of the stomach apart when the first and second elongateend effectors are engaged therewith and the first and second elongateend effectors are moved apart from one another, and wherein the oppositewalls are pulled apart without losing engagement of the first and secondelongate end effectors therewith.

In at least one embodiment, the first elongate end effector has a firstdistal end portion and a first proximal end portion and the secondelongate end effector has a second distal end portion and a secondproximal end portion, wherein the first and second elongate endeffectors are pivotally connected at the first and second proximal endportions, and wherein the first and second distal end portions includefirst and second free distal ends, respectively.

In at least one embodiment, the suction ports are elongated.

In at least one embodiment, the system further includes an elongateshaft extending proximally from proximal end portions of the first andsecond elongate members.

In at least one embodiment, the system further includes an actuatorlocated on a handle at a proximal end portion of the elongate shaft, theactuator being configured to actuate at least one function of theelongate end effectors.

In at least one embodiment, the system further includes a plurality ofsutures releasably engaged with the plurality of suture drivers,respectively.

In at least one embodiment, each suture extends through a suture lockreleasably provided on the third elongate end effector.

In at least one embodiment, each suture comprises an anchor mate mountedon a distal end portion thereof, the anchor mate being configured toengage with and connect to the anchor.

In at least one embodiment, the system further includes a layer ofmaterial configured to be placed adjacent to or between locations wherethe suture drivers from the third elongate end effector are configuredto pass through the stomach tissue and to the suture anchors on thefourth elongate end effector.

In at least one embodiment, the layer of material discourages ingrowthof tissue therein.

In at least one embodiment, the system further includes expandableimplant attached to or integral with the layer of material andconfigured to be implanted in a plication created by the instruments.

In at least one embodiment, the system further includes an expandableimplant configured to be implanted in a plication created by theinstruments.

In at least one embodiment, the system further includes a bougieconfigured to be temporarily placed in the stomach prior to forming aplication with the instruments.

In another aspect of the present invention, a method for decreasing theeffective volume of a patient's stomach is provided that includes:contacting a length of an end effector to an external surface of thestomach; forming a fold in the stomach and positioning the fold over aportion of the end effector; and simultaneously driving a plurality ofattachment members through the fold, wherein the attachment members areconfigured along a length direction relative to the end effector.

In at least one embodiment, forming a fold in the stomach comprisesforming a pair of folds in the stomach, and wherein positioning the foldover a portion of the end effector comprises positioning each of thepair of folds over portions of the end effector on opposite sides of theend effector.

In at least one embodiment, the attachment members through the fold arelocated in the upper third of the stomach.

In at least one embodiment, the method further includes withdrawing theend effector while leaving the attachment members in place in the fold.

In at least one embodiment, the method further includes attaching astrip to the fold via the attachment members, wherein the strip isconfigured to encourage tissue ingrowth on a side of the strip thatcontacts the fold.

In at least one embodiment, a side of the strip opposite the sideconfigured to encourage tissue ingrowth is configured to discouragetissue ingrowth.

In at least one embodiment, the method further includes installing adevice between an external surface of the stomach and the fold using theend effector.

In at least one embodiment, the method further includes withdrawing theend effector and drawing down the attachment members to securely implantthe device.

In at least one embodiment, the device is an expandable device, themethod further comprising expanding the device to further reduce theeffective volume of the stomach.

In at least one embodiment, the expandable device is fillable, andwherein the expanding is carried out by increasing an amount of fill inthe device.

In at least one embodiment, the fill comprises a fluid.

In at least one embodiment, the pair of folds are positioned over theopposite sides of the end effector using a grasping device and are heldin position by pushing the folds onto tissue pins on the end effector.

In at least one embodiment, the method further includes removing the endeffector after driving the attachment members through the folds andtightening the attachment members to draw portions of the folds intoserosa-to-serosa contact.

In at least one embodiment, the end effector engages tissue of thestomach and drives the tissue to perform the positioning of the fold.

In at least one embodiment, the end effector engages the tissue anddrives the tissue to perform the forming of a fold.

In at least one embodiment, opposite side portions of the end effectorengage tissue of the stomach and drive the tissue to perform thepositioning of the folds.

In at least one embodiment, the opposite side portions of the endeffector engage the tissue and drive the tissue to perform the forming apair of folds.

In at least one embodiment, the method further includes: inserting aguide tool within the stomach; and aligning the length of the endeffector with the stomach.

In another aspect of the present invention, a method for decreasing theeffective volume of a patient's stomach is provided that includes:contacting a length of an end effector to an external surface of thestomach; forming a pair of folds in the stomach and positioning thefolds over opposite side portions of the end effector; and connectingthe folds to one another.

In at least one embodiment, the folds are connected in serosa-to-serosacontact.

In at least one embodiment, the method further includes removing the endeffector after the connecting of the folds to one another.

In at least one embodiment, the method further includes overlaying aconjunction member on the folds to bridge the folds.

In at least one embodiment, the method further includes placing a devicebetween an external surface of the stomach and the folds.

In at least one embodiment, the device is an expandable device, themethod further comprising expanding the device to further reduce theeffective volume of the stomach.

In at least one embodiment, the expandable device is fillable, andwherein the expanding is carried out by increasing an amount of fill inthe device.

In at least one embodiment, the fill comprises a fluid.

In at least one embodiment, the method further includes: inserting aguide tool within the stomach; and aligning the length of the endeffector with the stomach.

In another aspect of the present invention, a method for decreasing theeffective volume of a patient's stomach is provided that includes:contacting an end effector carrying an implantable device to an externalsurface of the stomach; forming a pair of folds in the stomach andpositioning the folds over opposite side portions of the end effector;and connecting the folds to one another.

In at least one embodiment, the method further includes removing the endeffector while leaving the device in position between an externalsurface of the stomach and the pair of folds.

In at least one embodiment, the method further includes expanding thedevice to further reduce the effective volume of the stomach.

In another aspect of the present invention, an instrument for use inmodifying a patient's stomach by operating on the stomachextragastrically is provided that includes: an elongate end effector ata distal end portion of the instrument, the end effector having a distalend, a proximal end and first and second sides; an elongate shaftextending proximally from the proximal end of the end effector, theshaft having sufficient length so that a proximal end of the shaftextends out of the patient's body when the end effector is placed on thepatient's stomach; a plurality of piercing members extending lengthwisealong the end effector; and a plurality of attachment members extendinglengthwise along the end effector, the attachment members configured andpositioned to be driven through a fold in the stomach.

In at least one embodiment, the instrument further includes an elongatestrap configured and dimensioned to attach to the distal and proximalend of the end effector, to hold the fold in approximation to the endeffector.

In at least one embodiment, the plurality of piercing members arearranged along both sides of the end effector.

In at least one embodiment, the attachment members are arranged alongboth sides of the end effector.

In at least one embodiment, the instrument further includes a drivingmechanism configured to drive the fold over a side portion of the endeffector.

In at least one embodiment, the driving mechanism is configured to drivetissue of the stomach into a conformation comprising the fold.

In at least one embodiment, the instrument further includes a pair ofthe driving mechanisms one on the first side and one on the second side,the mechanisms configured to drive a pair of folds over opposite sideportions of the end effector.

In at least one embodiment, the instrument further includes receptaclesconfigured to receive and attach to the attachment members after theattachment members are driven through the fold.

In at least one embodiment, the instrument further includes aconjunction member connected to the plurality of attachment members.

In at least one embodiment, the conjunction member is connected to theattachment members via sutures.

In at least one embodiment, the lengths of the sutures between theconjunction member and the attachments members are adjustable.

In at least one embodiment, the conjunction member is configured toencourage tissue ingrowth on a first surface and is configured toprevent tissue ingrowth on an opposite surface.

In at least one embodiment, the instrument is provided in combinationwith an implantable device releasably attached to the instrument.

In another aspect of the present invention, a system for use inmodifying a patient's stomach by operating on the stomach extragastrically to decrease the effective volume of the patient's stomach isprovided including: an instrument including: an elongate end effector ata distal end portion of the instrument, the end effector having a distalend, a proximal end and first and second sides; an elongate shaftextending proximally from the proximal end of the end effector, theshaft having sufficient length so that a proximal end of the shaftextends out of the patient's body when the end effector is placed on thepatient's stomach; a plurality of piercing members extending lengthwisealong the end effector; and a plurality of attachment members extendinglengthwise along the end effector, the attachment members configured andpositioned to be driven through a fold in the stomach; and anexpandable, implantable device releasably attached to the instrument.

In at least one embodiment, the system further includes a drivingmechanism configured to drive a fold of the stomach tissue over thedevice and a side portion of the end effector.

In at least one embodiment, the system further includes a pair of thedriving mechanisms configured to drive a pair of folds of the stomachtissue over the device and opposite side portions of the end effector.

In at least one embodiment, the system further includes a conjunctionmember connected to the plurality of attachment members.

In at least one embodiment, the conjunction member is configured toencourage tissue ingrowth on a first surface and is configured toprevent tissue ingrowth on an opposite surface.

In another aspect of the present invention, a kit for use in modifying apatient's stomach by operating on the stomach extragastrically todecrease the effective volume of the patient's stomach is provided thatincludes: an implantable device comprising an elongate, tubularexpandable member configured and dimensioned to be implanted between afold created externally on the stomach and an external surface of thestomach; and a conjunction member having first and second oppositesurfaces, the first surface being configured to contact the fold andencourage tissue ingrowth; the second surface being configured toprevent tissue ingrowth.

In at least one embodiment, the device is configured and dimensioned tobe implanted between a pair of folds created externally on the stomachand an external surface of the stomach, and the conjunction member isconfigured to bridge and conjoin the two folds.

In at least one embodiment, the device further comprises a conduit influid communication with the expandable member, the conduit extendingfrom an end of the expandable member.

In at least one embodiment, the kit further includes a bougie configuredand dimensioned to be temporarily inserted in the stomach to function asa guide for placement of formation of the fold and placement of thedevice.

In at least one embodiment, an instrument for use in modifying apatient's stomach by operating on the stomach extragastrically todecrease the effective volume of the patient's stomach includes a firstelongate end effector formed at a distal end portion of said instrument,said first elongate end effector having a first operational surfaceconfigured to contact an external surface of the patient's stomach and afirst plurality of suction ports extending along a length of said firstelongate end effector and configured to deliver suction to the externalsurface of the stomach to engage said first elongate end effectortherewith, at least one suction port includes a means for providing aphysical barrier to the escape of a portion of the stomach from thesuction port.

In at least one embodiment, the instrument includes at least one suctionhole configured to hold the stomach against an interior surface of a lipof the suction port. In at least one embodiment, the at least onesuction hole is configured within a cavity of the suction port to createa concave curve in a portion of the stomach near the interior surface ofa lip of the suction port. In at least one embodiment, the suction portincludes at least one vacuum channel. In at least one embodiment, thesuction port includes a tissue excluder configured to exclude thestomach from the at least one vacuum channel.

In at least one embodiment, the suction port includes a resilient memberconfigured to deflect as suction is delivered to the external surface ofthe stomach. In at least one embodiment, the resilient member isconfigured to extend from the first operational surface toward theexternal surface of the stomach. In at least one embodiment, theresilient member includes at least one slot. In at least one embodiment,the resilient member is configured to extend parallel to an opening ofthe suction port. In at least one embodiment, the resilient member isconfigured to extend from an interior surface of the suction port.

In at least one embodiment, the instrument includes a second elongateend effector formed at a distal end portion of said instrument, saidsecond elongate end effector having a second operational surfaceconfigured to contact an external surface of the patient's stomach, anda second plurality of suction ports extending along a length of saidsecond elongate end effector and configured to deliver suction to theexternal surface of the stomach to engage said second elongate endeffector therewith, at least one suction port includes a means forproviding a physical bather to the escape of the stomach from thesuction port.

In at least one embodiment, the instrument includes a connector in fluidcommunication with the first elongate end effector and the secondelongate end effector. In at least one embodiment, the connectorincludes telescoping segments. In at least one embodiment, the connectoris biased to hold the first elongate end effector and the secondelongate end effector apart from each other. In at least one embodiment,the connector is biased to hold the first elongate end effector and thesecond elongate end effector together.

In at least one embodiment, an instrument for use in modifying apatient's stomach by operating on the stomach extragastrically todecrease the effective volume of the patient's stomach includes at leasttwo elongate end effectors formed at a distal end portion of saidinstrument, a plurality of suction ports extending along a length ofeach elongate end effector, and a resilient and flexible memberproximate at least one suction port wherein the member is configured toprovide a physical barrier to the escape of a portion of the stomachfrom the suction port.

In at least one embodiment, at least a portion of the member is withinthe suction port. In at least one embodiment, the member is entirelywithin the suction port. In at least one embodiment, the member isoutside the suction port.

In at least one embodiment, an instrument for use in modifying apatient's stomach by operating on the stomach extragastrically todecrease the effective volume of the patient's stomach includes at leasttwo elongate end effectors formed at a distal end portion of saidinstrument and a plurality of suction ports extending along a length ofeach elongate end effector and configured to deliver suction to theexternal surface of the stomach to engage each end effector therewith,wherein at least one port includes an interior lip configured tomaintain contact with the stomach when a portion of the stomach iswithin the suction port.

In at least one embodiment, the suction port includes channels. In atleast one embodiment, the suction port includes a tissue excluder. In atleast one embodiment, the suction port includes a suction hole proximatethe interior lip.

These and other features of the invention will become apparent to thosepersons skilled in the art upon reading the details of the instruments,implants, systems and methods as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates basic anatomy of the human stomach.

FIG. 1B is a partial, sectional illustration showing different layers ofthe stomach wall.

FIGS. 2A-2K illustrate various events for the performance of a procedurefor decreasing the effective volume of a patient's stomach that includesextragastric procedures on the stomach to create at least one plication,according to an embodiment of the present invention.

FIGS. 3A-3H are various views and partial views of an instrumentincluding end effectors for operating on a stomach extragastrically todecrease the effective volume of the stomach according to an embodimentof the present invention.

FIGS. 4A-4D illustrate a stomach that has been reduced in effectivevolume by a procedure according to an embodiment of the presentinvention.

FIGS. 5A-5L illustrate various events for the performance of a procedurefor decreasing the effective volume of a patient's stomach that includesextragastric procedures on the stomach to create at least one plication,according to another embodiment of the present invention.

FIGS. 5M-5R schematically illustrate an alternative embodiment to theinstrumentation used in FIGS. 5A-5L, according to an embodiment of thepresent invention.

FIG. 6 illustrates an instrument that can function as a bougie,according to an embodiment of the present invention.

FIGS. 7A-7I illustrate various events for the performance of a procedurein which a device is implanted within plications formed at externallocations of the stomach according to an embodiment of the presentinvention.

FIGS. 8A-8S are various views and partial views of an attachmentinstrument according to an embodiment of the present invention, and of amethod of performing a plication therewith according to an embodiment ofthe present invention.

FIG. 9 is a schematic illustration of an alternative mechanism formaking a stitch (or simultaneous stitches) through tissue according toan embodiment of the present invention.

FIGS. 10A-10J illustrate various events for the performance of aprocedure in which a device is implanted within plications formed atexternal locations of the stomach according to an embodiment of thepresent invention.

FIGS. 11A-11S illustrate various events for the performance of aprocedure in which a device is implanted within plications formed atexternal locations of the stomach according to an embodiment of thepresent invention.

FIGS. 12A and 12G-12I are various views of an end effector according toan embodiment of the present invention.

FIGS. 12B-12F illustrate a method of using the end effector of FIGS. 12Aand 12G-12I according to an embodiment of the present invention.

FIGS. 13A-13G show various views of an end effector according to anotherembodiment of the present invention and a method of using it accordingto another embodiment of the present invention.

FIGS. 14A-14B are a top view and perspective view, respectively, of anend effector according to another embodiment of the present invention.

FIGS. 15A-15E are various views showing an instrument that includessuction for holding stomach tissue in place during a plicationprocedure, and use thereof, according to an embodiment of the presentinvention.

FIGS. 16A-16D illustrate use of vacuum to ascertain proper placement ofplicated tissue according to embodiments of the present invention.

FIGS. 17A-17E are various views of an attachment instrument and usethereof, according to another embodiment of the present invention.

FIGS. 18A-18H are various views illustrating an instrument and usethereof to perform a plication according to embodiments of the presentinvention.

FIGS. 19A-19B are views of an instrument and stomach illustrating use ofthe instrument to perform a plication according to another embodiment ofthe present invention.

FIGS. 20A-20B illustrate use of an instrument to perform a plicationaccording to another embodiment of the present invention.

FIGS. 21A-21C illustrate a method of performing a plication according toanother embodiment of the present invention.

FIGS. 22A-22B illustrate a device and a method of performing a plicationaccording to another embodiment of the present invention.

FIGS. 23A-23E are various view of an instrument for performing plicationaccording to another embodiment of the present invention.

FIGS. 24A-24D are various views of another instrument for use inperforming plication, according to an embodiment of the presentinvention.

FIGS. 25A-25B are views of another instrument for use in performingplication, according to an embodiment of the present invention.

FIGS. 26A-26D illustrate various events in performing a plicationaccording to another embodiment of the present invention.

FIGS. 27A-27B illustrate an instrument and performance of a plicationaccording to another embodiment of the present invention.

FIGS. 28A-28G illustrate an instrument and use thereof for forming aplication as well as functioning as a bougie according an embodiment ofthe present invention.

FIGS. 29A-29D illustrate an instrument and use thereof for forming aplication as well as functioning as a bougie according an embodiment ofthe present invention.

FIGS. 30A-30D illustrate an instrument for deforming tissues to besutured and suturing the tissues, according to an embodiment of thepresent invention.

FIGS. 31A-31B illustrate a plan view and a partial view, respectively,of a view of an instrument that can be used to manipulate stomach tissuein furtherance of a plication procedure according to an embodiment ofthe present invention.

FIGS. 32A-32C illustrate an instrument for use in performing a plicationaccording to another embodiment of the present invention.

FIG. 33 illustrates instruments for use in performing a plicationaccording to another embodiment of the present invention.

FIG. 34 illustrates an implant according to an embodiment of the presentinvention.

FIGS. 35A-35F are various views of an instrument for use in performing aplication according to another embodiment of the present invention.

FIGS. 36A-36B are views of an instrument for use in performing aplication that is completed by manual suturing according to anembodiment of the present invention.

FIG. 36C illustrates manual suturing of a plication line according to anembodiment of the present invention.

FIGS. 36D-36E are perspective and cross-sectional illustrations,respectively, of a stomach having a plication with two suture linesinstalled according to an embodiment of the present invention.

FIGS. 36F-36G are perspective and cross-sectional illustrations,respectively, of a stomach having a plication with one suture lineinstalled according to an embodiment of the present invention.

FIGS. 37A-37C are schematic views illustrating a mechanism for engagingstomach tissue according to an embodiment of the present invention.

FIGS. 38A-38H provide various partial views of an instrument thatemploys suction as a primary clamping feature and a mechanical secondaryclamping feature according to an embodiment of the present invention.

FIGS. 39A-39K illustrate various events for the performance of aprocedure for decreasing the effective volume of a patient's stomachthat includes extragastric procedures on the stomach to create at leastone plication, according to another embodiment of the present invention.

FIGS. 40A-40F illustrate various attachment tabs or fins accordance tovarious embodiments of the present invention.

FIGS. 41A-41E illustrate various schematic views and partial views of adriving mechanism according to an embodiment of the present invention.

FIGS. 42A-42B illustrate partial schematic views of an end effectorhaving a driving mechanism according to another embodiment of thepresent invention.

FIGS. 43A-43C illustrate arrangements and methods for installing arunning stitch using an attachment instrument according to variousembodiments of the present invention.

FIGS. 44A-44B illustrate views of an embodiment of a handle portion ofan instrument capable of operating end effectors designed according tocertain aspects of the present invention.

FIGS. 45A-45C illustrate views of various clamping mechanisms for usewith end effectors according to certain embodiments of the presentinvention.

FIGS. 46A-46B illustrate views of an end effector assembly includingtelescoping connectors according to certain embodiments of the presentinvention.

FIGS. 46C-46F illustrate views of various suction connectors for usewith end effectors according to certain embodiments of the presentinvention.

FIGS. 47A-47N illustrate views of various suction ports for use with endeffectors according to certain embodiments of the present invention.

FIGS. 48A-48B illustrate perspective views of a modular system of endeffectors and suction ports according to certain embodiments of thepresent invention.

FIGS. 49A-49B illustrate views of a mechanism for engaging stomachtissue according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Before the present systems, devices and methods are described, it is tobe understood that this invention is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present invention will be limited onlyby the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are now described. All publications mentioned herein areincorporated herein by reference to disclose and describe the methodsand/or materials in connection with which the publications are cited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “asuture” includes a plurality of such sutures and reference to “theanchor” includes reference to one or more anchors and equivalentsthereof known to those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Stomach Anatomy

The stomach 3 is divided into four sections, as indicated by the dashedlines on FIG. 1A. The cardia 3C (see FIG. 1A) is the section thatreceives the contents of the esophagus 4 to be delivered into thestomach 3. The fundus 3F is the section formed by the upper curvature ofthe stomach 3. The body 3B is the main, central region of the stomach,and the pylorus 3P is the lower section of the stomach 3 thatfacilitates emptying of the contents of the stomach 3 into the smallintestine/duodenum. The region between the body 3B and pylorus 3P isreferred to as the pyloric antrum 3PA. The greater curvature 3G of thestomach is directed mainly forward and is typically about four or fivetimes as long as the lesser curvature 3L of the stomach, that is formedon the opposite side of the stomach 3 from the greater curvature 3G.

The stomach wall is made up of layers of tissues. The serosa or serosallayer 3S forms the outer layer of the stomach wall 3W, see FIG. 1B, andcovers the muscularis layer 3M. The mucosa or mucosal layer 3MU formsthe inner lining of the stomach, and the submucosal layer 3SMinterconnects the mucosa 3MU with the muscularis 3M.

Methods, Instruments, Devices and Systems

The present invention provides methods, instruments, devices and systemsfor reducing the effective volume of a stomach by performing one or moreextragastric plications of the stomach. As noted, the plications areperformed from outside of the stomach. In some, but not all embodiments,the plication results from attachment that does not penetrate throughthe entire wall of the stomach. Preferably, in performing plication, theone or more plications formed place stomach tissue in serosa to serosacontact, wherein the stomach is folded in on itself and connected inplace. Procedures described are repeatable to reliably form a pathwaythrough the stomach that is substantially tube-shaped and which has adiameter which is not too small anywhere along the length thereof toraise an unacceptable risk of obstruction, but which is not too largeanywhere along the length thereof to render its weight loss results lesseffective than expected. In one category, typically, but not necessarilyperformed by a laparoscopic or percutaneous procedure, only connectorsare left in place at the surgical site upon formation of one or moreplications. In a second category, a device is inserted within one ormore plications, between external wall surfaces of the stomach 3, and isfixed in place there using connectors. Connectors are also used tomaintain the plications in place. Preferably the size/volume of thedevice is adjustable, so that it can be adjusted, after implantation, toprovide more or less reduction in the overall internal stomach space. Itis noted that although certain embodiments are described with regard topracticing a procedure in the first category, and other specificembodiments are described in regard to practicing a procedure in thesecond category, the invention is not limited to these embodiments, andeach embodiment of instrument/system described can be used to practiceeither category of procedure unless it would be physically impossible todo so. Also, it is noted that certain features of instruments aredescribed with regard to a particular embodiment, but these features maybe interchangeable with other embodiments described herein.

In at least one embodiment, the omentum is dissected from the greatercurvature of the stomach. The stomach is rolled up, starting from thegreater curvature, toward the lesser curvature, and then the rolled upportion is stitched along at least the superior portion (upper one thirdof the stomach) to create a pouch and narrowing near the top of thestomach. Optionally an extragastric, expandable implant may be placed incontact with the rolled up portion to provide further assurance ofprevention of unrolling and to provide further adjustability of theremaining pouch and sleeve formed by the rolling and stitching.

Referring now to FIGS. 2A-2K, various events are illustrated for theperformance of a procedure for decreasing the effective volume of apatient's stomach that includes extragastric procedures on the stomachto create at least one plication, typically a plication including atleast a portion of the greater curve 3G of the stomach 3. Accordinglythese procedures can be referred to as “greater curve plication”procedures. The procedure shown in FIGS. 2A-2K is a laparoscopicprocedure in which ports are installed in a patient for access to theabdominal cavity by not only the instrument shown, but also by otherinstruments typically used in laparoscopic surgery, such as graspers,endoscope, etc.

After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve 3G of the stomach 3 to provide access thereto, see FIGS.2A-2B. A bougie 50 is inserted trans-esophageally and placed in thestomach 3 in a position such as shown in FIG. 2C. Typically the bougieoccupies a pathway extending naturally from the esophagus, through thestomach 3 and into the pylorus 3P, so as to occupy a space similar towhat is defined when a sleeve gastrectomy is performed. In one example,the bougie 50 was a size 32 French outside diameter, although this sizemay vary, up to and including 38 French and 40 French, for example. Thebougie 50 acts as a guide so as to better standardize the size(s) andlocation(s) of plication(s) formed by the procedure as well as toprevent reducing the stomach too aggressively, so as to ensure noblockage locations are inadvertently formed.

An attachment instrument 100 is inserted into the abdominal cavity and aworking end is positioned over a location on the stomach where aplication line is intended to be formed. The working end is the distalend portion of the instrument 100 and includes a first end effector100E1 and a second end effector 100E2 extending alongside and opposingfirst end effector 100E1. One of the end effectors 100E1, 100E2 isplaced on a posterior surface of the stomach and the other is placed onan anterior surface of the stomach along a line opposed to a line of theposterior surface that the first end effector contacts. In theembodiment shown in FIG. 2D, end effector 100E1 is contacted to theanterior surface, and end effector 100E2 is contacted to the posteriorsurface. Alternatively, end effector 100E1 could be contacted to theposterior surface, and end effector 100E2 could be contacted to theanterior surface. The end effectors 100 are positioned close to thebougie 50 so that the diameter of the bougie defines the resulting lumenin the stomach after the plication has been sutured. Optionally, the endeffectors may have features that can be adjusted by the surgeon. Thesefeatures would extend the width of the end effector on the side that isclosest to the bougie. This would enable the surgeon to adjust how closethe suturing can be placed relative to the bougie. These adjustmentscould be made differently at the most distal end of the end effectors,compared to the most proximal ends of the end effectors. In this manner,the surgeon could make adjustments to cause the ultimate size of thestomach's lumen to be tighter at the antrum end of the stomach, andlooser at the fundus of the stomach, or vice versa. Another option isthat the diameter of the bougie can be changed. With the bougie used asa guide for the initial positioning of the end effectors on thestomach's surface such that the end effectors are placed immediatelyadjacent to the bougie prior to gripping the stomach, the diameter orwidth of the bougie after gripping but prior to imbricating the stomachcan be reduced to allow space between the bougie and the end effectorsfor the imbricated stomach tissue. This could be accomplished with atwo-part bougie, one part of which is removed prior to imbrication, orwith an inflatable bougie that allows its diameter to be adjusted whilein place.

The end effectors 100E1, 100E2 engage the surfaces of the stomach thatthey are contacted to by application of negative pressure throughsuction ports defined in the contact surfaces of the end effectors,which are described in further detail below. The engagement forces aresufficiently strong so that when the end effectors 100E1, 100E2 areseparated (moved away from one another) as illustrated in FIG. 2E, theportions of the stomach wall engaged by the end effectors are also drawnapart, thereby expanding the interior volume within the stomach.Alternative to moving both end effectors 100E1, 100E2 apart from eachother, end effector 100E2 can be maintained stationary while endeffector 100E1 is move away from it or end effector 100E1 can bemaintained stationary while end effector 100E2 is moved away from it.

Next, a portion of the stomach forming at least a portion of the greatercurvature 3G is plicated, i.e., tucked, into the gap 100G formed byseparating the end effectors 100E1, 100E2 as illustrated in FIG. 2F. Theplicated portion of the stomach is folded to an extent that it islocated on the opposite side of the intended plication line, relative toits pre-plicated location, as can be observed by comparing FIG. 2E withFIG. 2F. Optionally, but preferably, prior to plicating the portion ofthe stomach, the operator of the instrument 100 may rotate theinstrument by about ninety degrees (counterclockwise in the embodimentshown in optional step of FIG. 2F′) about its longitudinal axis. Thisoption positions the stomach to allow gravity to assist in plicating theportion 3G through the gap 100G, making the plicating much easier as theportion 3G “falls” in through gap 100G.

Once the portion 3G has been plicated appropriately according to eitheroptional technique described above, the instrument 100 is then operatedto move the end effectors 100E1, 100E2 together again thereby closingthe plication as illustrated in FIG. 2G. During this step, andthroughout the following steps, the instrument can be maintained in therotated orientation (as shown in FIG. 2F′) or it can be rotated back tothe original orientation shown in FIG. 2G. Next instrument 100 isoperated to attach the folded tissue surfaces of the stomach together inserosa-to-serosa contact to hold the plication. At FIG. 2H piercingmembers/suture drivers 102 (preferably needles, but could alternately bescrew drives or other elongated members configured to temporarily attachattachment members/sutures to and to drive through the stomach tissues)are deployed from end effector 100E1 to drive attachment members/sutures104 through the stomach tissues as shown. It should be noted that whileFIG. 2H shows the needles penetrating the stomach tissue in a mannerwhere they penetrate through four walls of tissue, the device canalternatively be configured to control the stomach tissue into aposition with the location of the suction features such that the needlespierce closer to the edges of the folds. This would enable the needlesand suture to transect the wall thickness of the stomach, but not breachthe inner surface of the stomach. This alternative approach can be takenfor all of the various embodiments described herein. Suture anchors 106are removably held in end effector 100E2 and are aligned with thepiercing member/suture drivers 102. Attachment members/sutures 104 arereleasably engaged with piercing members/suture drivers 102. In theembodiment shown in FIG. 2H, attachment members/sutures 104 are eachprovided with an anchor mate 108 on a distal end portion thereof,preferably at the distal end thereof. Anchor mate 108 is configured toslide over the tapered distal end portion of the suture driver 102, butis prevented from sliding further proximally by the increasing diameterof the taper of the driver 102 distal end portion. The exterior of theanchor mate 108 is also tapered, so that the distal end 108D thereof isof a smaller cross-sectional dimension than the proximal end 108Pthereof. This facilitates the driving of the anchor mate 108 into theanchor 106 as shown in FIG. 2H. However, upon withdrawal of the suturedriver, the proximal end of the anchor mate 108P is retained by theanchor 106 and the anchor mate 108 slides off the suture driver 102,thereby leaving the anchor mate 108 and suture 104 installed through thetissues as illustrated in FIG. 2I. The end effectors 100E1, 100E2 aredesigned so that the suture connection elements 102, 104, 106, 108 arerepeated along the length of the end effectors, spaced approximately0.75″ from center to center. These repeated elements therefore deploythe suture connection along the length of the desired plication line. Itis noted here that if the optional rotation is performed in FIG. 2F′,then the instrument is counter-rotated by the amount about thelongitudinal axis thereof, to return the stomach to the orientationshown in FIG. 2G or FIG. 2H, either after performing the proceduresdescribed above with regard to FIG. 2G or after performing theprocedures described above with regard to FIG. 2H.

Attachment members/sutures 104 are also pre-installed through suturelocks 110 that are removably mounted on end effector 100E1 and aremounted on attachment members/sutures 104 proximal to the piercingmembers/suture drivers 102. Once the attachment members/sutures havebeen driven and anchored as illustrated in FIG. 2H and the stomach hasbeen rotated back to its original orientation, if applicable, instrument100 is removed from the patient, leaving the attachment members/sutures104, suture locks 110, suture anchors 106 and suture anchor mates 108 inplace as illustrated in FIG. 2I. Suture locks 110 have a one-way lockingmechanism, such as a ratcheting type mechanism or other arrangement suchas directionally oriented teeth that allow suture 104 to be pulledproximally therethrough, but which prevent attachment members/sutures104 from backsliding distally therethrough. At FIG. 2J, the attachmentmembers/sutures 104 are cinched by pulling them proximally relative tothe suture locks 110 until a desired amount of tension is developed inthe attachment members/sutures 104. The attachment members/sutures arecinched tight enough to bring the tissue surfaces into firm contactwithout creating tissue necrosis or overtightening. Cinching can beperformed by the use of laparoscopic graspers (not shown), for example.The bougie 50 can then be removed from the patient and the patient canbe closed, according to known techniques, to complete the procedure.Alternatively, the suture locks 110 can be located in end effector100E1, but on the posterior side in contact with the stomach tissue.Alternatively, the instrument 100 can be left in place until after thesutures 104 are cinched tight and trimmed by the instrument 100, andafterwards the instrument 100 can be removed, leaving the result shownin FIG. 2J. Alternatively, staples or other fasteners could be used inplace of the sutures, suture locks, suture anchors and mating anchors.

As a further option, an expandable implant 10 may be implanted to fillthe inside of the plication 3PL as illustrated in FIG. 2K. The implantmay be a silicone bladder, for example, capable of being inflated bybiocompatible fluid such as liquid, gas, or a combination of fluids(gases, liquids, or liquids and gases). Implant 10 is connected in fluidcommunication to a subcutaneous fill port 80 via fill tube 12 (such asillustrated in FIG. 7H, for example, and described in detail in ourprevious applications which have been incorporated herein, in theirentireties, by reference thereto). Subcutaneous fill port 80 can beaccessed after completion of the procedure to adjust the fill volume(either increase or decrease) of implant 10. Other implants 10 may besubstituted, but need to be expandable and are preferably controllableas to amount of expansion. A tab or wing 11, 11′, 11″, 11″′ may beprovided to extend from the expandable body of the implant 10 and can beinserted between the tissue folds at the plication suture line so thatthe attachment members/sutures 104 are also installed through the tab orwing 11, 11′, 11″, 11″′ to thereby securely hold the implant in place,as illustrated in FIG. 2K. The tab or wing 11, 11′, 11″, 11″′ may bemade of a mesh-reinforced silicone, for example. Alternatively, all or aportion of tab or wing 11, 11′, 11″, 11″′ may be made of a tissueingrowth encouraging material such as DACRON or the like. Alternatively,the implant may be fixed in place by connecting only to the superior andinferior ends of the plication suture line, or by connecting to one ormore of the suture locks 110 and/or suture anchors 106. By making theexteriors of the tab or wing 11, 11′, 11″, 11″′ of silicone, this willprevent tissue ingrowth, rendering the sutured plication procedurereversible. Alternatively, by providing the mesh layers on thesurface(s) of the tab or wing 11, this will encourage tissue ingrowth,thereby reinforcing the joinder of the serosa-to-serosa plication line.Alternatively, the wing 11, 11′, 11″, 11″′ can have a shape along itslength that is castellated with extensions and indentations, where theextended sections along the length engage with the sutures 104, andwhere the indentations between the extensions allow the serosa to serosacontact between the stomach tissues to remain and allow for adhesion andtissue ingrowth. The tab or wing 11,11′,11″,11′″ may be a fin, which maybe longitudinally extending such that it has a length greater than widthsuch as illustrated in FIGS. 40A-4F, such that it extends along theimplant 10 by a greater distance than the distance that it extends fromthe implant 10. Alternatively, the tab 11,11′,11″,11′″ could extend fromthe implant 10 by a distance greater than a distance that it extendsalong the implant 10. The fin may be continuous, porous, or may consistof a series of fingers. The embodiments are shown as linear embodiments,but it is within the scope of the present invention that the implant andtab, wing or fin be curved or that the tab, wing or fin be curved, orthat the tab, wing or fin may be discontinuous in the length direction.FIGS. 40A-40B illustrate an embodiment in which fin 11′ includes aplurality of fingers 11F with gaps 11G therebetween. FIGS. 40C-40F showembodiments of fins 11″ and 11′″, respectively, each having pores 11Ptherethrough. Pores 11P may be dimensioned to allow tissue to growbetween and across on either side of the fin 11″, 11′ (and through pores11P). The plication attachment devices described herein may be designedto attach within/through the pores 11P/gaps 11G or through the solidregions 11S between the pores 11P/gaps 11G. The fingers 11F may bespaced so that they traverse the space between the plication attachmentlocations or they may be captured in part or in full under thelocations/attachment points on the instrument. The material of the fin11, 11′, 11″, 11″′ may be of a tissue ingrowth preventing material suchas silicone or the like, or may be made partly or entirely of amesh-like or tissue ingrowth promoting material such as DACRON or thelike. The fin 11, 11′, 11″, 11″′ should have enough flexibility to beadhered within the plication yet minimize the force imparted by thedevice on the attachment points. The fin 11, 11′, 11″, 11″′ may have acoupling region that temporarily aligns it with the plication attachmentinstrument so that it is properly located while the plicationattachments are being formed.

FIG. 3A is a perspective view of instrument 100 including end effectors100E1 and 100E2 for operating on the stomach extragastrically todecrease the effective volume of the patient's stomach according to anembodiment of the present invention. First and second elongate endeffectors 100E1, 100E2 are formed at a distal end portion of instrument100. End effector 100E1 has an operational surface 100ES1 configured tocontact an external surface of the patient's stomach 3 and end effector100E2 has an operational surface 100ES2 configured to contact anexternal surface of the patient's stomach on a location opposite ofwhere the first elongate end effector 100E1 is configured to contact theexternal surface of the stomach, and operational surface 100ES2 opposesoperational surface 100ES1 as shown best in FIG. 3B.

A plurality of suction ports 112 are formed in both end effectors 100E1,100E2. Suction ports 112 are oriented to extend along a length of eachend effector, and are in fluid communication with a source of negativepressure (not shown) provided outside of the patient, proximal of thehandle 114 on the proximal end portion of instrument 100 (see FIG. 1).For example, a suction line 116 that is in fluid communication withports 112 may extend proximally from handle 114 and be configured forconnection to a source of negative pressure, such as the suction systemof an operating room or other source of negative pressure. Thus the endeffectors 100E1, 100E2 are configured to deliver suction to the externalsurfaces of the stomach 3 to engage the surfaces.

The end effectors 100E1, 100E2 are substantially equal in length andhave a length at least greater than half the length of the stomach, morepreferably a length nearly as long as or even longer than the length ofthe stomach. The length is typically a length selected from a range oflengths of instruments. The instrument 100 may be manufactured as aplurality of models having end effectors with different lengths so as toaccommodate various lengths of patient's stomachs.

As noted above and illustrated with regard to FIGS. 2D-2E, suction ports112 are configured to apply suction in an amount sufficient to pullopposite walls of the stomach apart when the end effectors 100E1, 100E2are engaged therewith and are moved apart from one another. This pullsthe opposite walls apart without losing engagement of the end effectorswith the walls.

The end effectors 100E1 and 100E2 are pivotally connected at proximalend portions thereof as shown in FIGS. 3A, 3E, 3G and 3H by jointmechanism 118. Joint mechanism 118 is a complex joint mechanism thatfacilitates not only pivoting of the end effectors relative to oneanother as illustrated in FIGS. 3A and 3E, but also allows the endeffectors to be moved non-rotationally, such that they remain parallelto one another over a range of motion from a closed configuration (seeFIG. 3G) to and open configuration (see FIG. 3H). Accordingly,instrument 100 can be operated to place the end effectors 100E1, 100E2into the open configuration of FIG. 3H in which the end effectors arespaced apart but parallel to one another. End effectors 100E1, 100E2 canfurther be pivoted relative to one another to further separate the freedistal ends thereof by a separation distance greater than the distancebetween the proximal ends thereof, as shown in FIG. 3A. This facilitatesthe positioning of the end effectors over the external posterior andanterior surfaces of the stomach. Once the end effectors 100E1, 100E2have been positioned over the intended location of the plication sutureline, instrument 100 can be operated to pivot/rotate the end effectors100E1, 100E2 in the opposite direction to return them to the openposition shown in FIG. 3H so that the end effectors are once againparallel to one another. Then the end effectors 100E1, 100E2 are movedtoward the closed position, but only by an amount sufficient to closethe folded stomach tissues therebetween, but not so much as to riskcausing necrosis or other unnecessary tissue damage. The movements ofthe end effectors are such that they remain parallel to one another overthe entire course of this clamping action. Alternatively, the linkagecan allow the end effectors 100E1, 100E2 to close so that the proximalend is slightly further apart than the distal end in order to compensatefor the typically thicker stomach tissue near the antrum as compared tothe thinner tissue near the fundus. The desired amount of clamping maybe determined visually by the surgeon and/or feedback from one or moresensors such as a strain gauge or the like that may be provided in oneor both of the end effectors (not shown). Alternatively, a linkage maybe present at both the proximal end (as shown) and also at the distalend of the end effectors. If a linkage is present at both ends, it canprovide improved alignment between the end effectors 100E1, 100E2, andalso provide a stronger clamping force which can be advantageous whenthe suture connections are being deployed. Alternatively, the linkagesat both ends can be replaced by a telescoping connection such as a pinthat extends from a tubular hole as the end effectors 100E1, 100E2separate. In such a configuration, the clamping together of the endeffectors could be accomplished by the device pulling on cables that areconnected to the pin at each end, thereby drawing the pins back intotheir mating tubular holes and thereby drawing the end effectors backtogether. This configuration can advantageously draw the ends of the endeffectors to varying degrees of closeness that are adjustable toaccommodate varying thicknesses of stomach 3 tissue. For example, thedistal end of the end effectors could be drawn together closer to clamparound the thinner tissue in the fundus area, compared to the thickerantrum area, where the end effectors could be drawn together less.

Handle 114 is mounted on a proximal end portion of an elongated shaft120 that connects the end effectors 100E1, 100E2 and connectionmechanism 118 therewith, see FIG. 3A. Shaft 120 houses suction line 116as well as control cables connecting actuator 122 with a mechanism fordriving piercing members/suture drivers 102. Shaft 120 has a lengthsufficient to position handle 114 outside of the body of the patientwhen end effectors 100E1, 100E2 are contacted to and engaged withstomach tissue in a manner as described above. Once the end effectors100E1, 100E2 have been clamped to close the plication by a sufficientforce as described above and illustrated in FIG. 2G, actuator 122 issqueezed to actuate the driving of the piercing members/suture drivers102 as illustrated in FIG. 2H.

As shown in FIG. 3C, the suture locks 110 are removably mounted to theoperational surface 100ES1 of end effector 100E1. As shown in FIG. 3D,the suture anchors 106 are removably mounted to the operational surface100ES2 of end effector 100E2. FIG. 3E is a partial view of theinstrument 100 (distal end portion view) showing the piercingmembers/suture drivers partially retracted after firing. FIG. 3F is anenlarged detail view of the distal end of the end effector 100E1 of FIG.3F that shows the suture driver 102, suture 104, suture lock 110 andanchor mate 108. As also shown in FIG. 3C-3D, suction ports arepreferably shaped as elongated slots that are elongated in the directionof the longitudinal axes of the end effectors. FIG. 3G shows the endeffectors 100E1, 100E2 in a clamped configuration. FIG. 3H shows the endeffectors 100E1, 100E2 in an unclamped configuration in which they arespaced apart to provide a gap therebetween. It is noted that thejoint/linkage 118 is configured to move the end effectors such that theyremain substantially parallel to one another when moving between theclamped and unclamped configurations, but that it is also configured topivot the end effectors relative to one another, as illustrated in FIGS.3A and 3E.

FIGS. 4A-4D are photos of a stomach 3 after performing the proceduredescribed above with regard to FIGS. 2A-2E, 2F′ and 2G-2J. With thisprocedure, there are no anchors or attachment mechanisms left in thestomach. As such the stomach does not have any objects or items in itthat it would otherwise try to digest or expel. In FIG. 4A, the stomach3 has been rotated 90 degrees about is longitudinal axis so to show theposterior side of the stomach 3, showing the mating anchors 108 matedwith the suture anchors 106 along the posterior side of the plicationline 3PL. In FIG. 4B, the stomach 3 has been counter-rotated by 90degrees from that in FIG. 4A to show the anterior side of the stomach 3.The suture locks 10 can be seen extending along the plication line 3PLand sutures 104 have been cinched but not yet trimmed. FIG. 4C is ananterior view of the stomach, like FIG. 4B, but wherein the bougie 50has been removed from the stomach 3 by pulling it out of the esophagus 6and the sutures 104 have been trimmed off adjacent the suture locks.FIG. 4D is a posterior view of the stomach 3, like FIG. 4A, but wherethe bougie 50 has been removed from the stomach.

FIGS. 5A-5L illustrate various events for the performance of a procedurealternative to the embodiments described above with regard to FIGS.2A-2K, for decreasing the effective volume of a patient's stomach thatincludes extragastric procedures on the stomach to create at least oneplication, typically a plication including at least a portion of thegreater curve 3G of the stomach 3. Accordingly these procedures can bereferred to as “greater curve plication” procedures. The proceduresshown are laparoscopic procedures in which ports are installed in apatient for access to the abdominal cavity by not only the instrumentsshown, but also by other instruments typically used in laparoscopicsurgery, such as graspers, endoscope, etc.

After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve 3G of the stomach 3 to provide access thereto, see FIGS.5A-5B. A bougie 50 is inserted trans-esophageally and placed in thestomach 3 in a position such as shown in FIG. 5C. Typically the bougie50 occupies a pathway extending naturally from the esophagus, throughthe stomach 3 and into the pylorus 3P, so as to occupy a space similarto what is defined when a sleeve gastrectomy is performed. The bougie 50acts as a guide so as to better standardize the size(s) and location(s)of plication(s) formed by the procedure as well as to prevent reducingthe stomach too aggressively, so as to ensure no blockage locations areinadvertently formed.

In the embodiments of FIGS. 5D-5L the functions of instrument 100 aredivided among two instruments 200 and 250. Engagement instrument 200 isconfigured like instrument 100, but without the piercing members/suturedrivers 102, attachment members/sutures 104, anchors 106, anchor mates108, suture locks 110 or any of the actuation mechanisms for driving andattaching attachment members/sutures. However, suction ports 112 areprovided in both end effectors in the same manner and connection/jointmechanism 118 is provided and functions in the same manner. Alsoincluded are shaft 120, handle 114 and suction line 116. Stitchinginstrument 250 is configured like instrument 100 with the piercingmembers/suture drivers 102, attachment members/sutures 104, anchors 106,anchor mates 108, suture locks 110 and actuation mechanisms therefore,but without suctions ports 112 (although, optionally, suction ports maybe included in the end effectors of instrument 250) or connection/jointmechanism. Also included are shaft 120, handle 114 and, optionally,suction line 116.

Engagement instrument 200 is inserted into the abdominal cavity and aworking end thereof is positioned over a location on the stomach 3 wherea plication line 3PL is intended to be formed. The working end is thedistal end portion of the instrument 200 and includes a first endeffector 200E1 and a second end effector 200E2 extending alongside andopposing first end effector 200E1. One of the end effectors 200E1, 200E2is placed on a posterior surface of the stomach 3 and the other isplaced on an anterior surface of the stomach 3 along a line opposed to aline of the posterior surface that the first end effector contacts. Inthe embodiment shown in FIG. 5D, end effector 200E1 is contacted to theanterior surface, and end effector 200E2 is contacted to the posteriorsurface. Alternatively, end effector 200E1 could be contacted to theposterior surface, and end effector 200E2 could be contacted to theanterior surface.

The end effectors 200E1, 200E2 engage the surfaces of the stomach 3 thatthey are contacted to by application of negative pressure throughsuction ports defined in the contact surfaces of the end effectors,which are described above in further detail. The engagement forces aresufficiently strong so that when the end effectors 200E1, 200E2 areseparated (moved away from one another) as illustrated in FIG. 5E, theportions of the stomach wall engaged by the end effectors are also drawnapart, thereby expanding the interior volume within the stomach 3.

Next, a portion of the stomach forming at least a portion of the greatercurvature 3G is plicated (i.e., tucked) into the gap 200G formed byseparating the end effectors 200E1, 200E2 as illustrated in FIG. 5F. Theplicated portion of the stomach 3 is folded to an extent that it islocated on the opposite side of the intended plication line, relative toits pre-plicated location, as can be observed by comparing FIG. 5E withFIG. 5F. Optionally, but preferably, prior to plicating the portion ofthe stomach 3, the operator of the instrument 200 may rotate theinstrument 200 by about ninety degrees (counterclockwise in theembodiment shown in optional step of FIG. 5F′). about its longitudinalaxis. This option positions the stomach 3 to allow gravity to assist inplicating the portion 3G through the gap 200G, making the plicating mucheasier as the portion 3G “falls” in through gap 200G.

Once the portion 3G has been folded appropriately according to eitheroptional technique described above, the instrument 200 is then operatedto move the end effectors 200E1, 200E2 together again thereby closingthe plication as illustrated in FIG. 5G. Next the surgeon can use astandard laparoscopic needle driver and needle with suture attachedthereto, to suture the plication manually. Alternatively, instrument 250is mounted over the folded tissue layers of the plication so that thirdend effector 250E1 and fourth end effector 250E2 contact the tissues onopposite sides thereof as shown in FIG. 5H. Instrument 250 fits in gapsin the instrument 200 between suction ports 112. Additionally, a layerof material is mounted in instrument 250 which wraps around from theoperation surface of end effector 250E1 to the operational surface ofend effector 250E2 (see FIG. 5G) and overlies the locations of theoperational surfaces where the piercing members/suture drivers aredriven out from, as well as the locations where the suture anchors areremovably mounted. After mounting as described, instrument 250 isoperated to attach the folded tissue surfaces of the stomach together inserosa-to-serosa contact to hold the plication. At the same time thelayer of material 230 is attached to the plication. Material 230 forms abarrier layer that spans the suture line to prevent herniation of theplicated stomach in between the attachment members/sutures, therebygreatly reducing the risk of ischemia. The barrier material may be asheet or strip of silicone, with or without mesh reinforcement, forexample. Whether or not reinforced, the exterior of the strip issilicone, to prevent tissue ingrowth. By preventing tissue ingrowth,this will facilitate reversal of the procedure/plication as the siliconestrip will be easily removable. At FIG. 5H piercing members/suturedrivers 102 (preferably needles, but could alternately be screw drivesor other elongated members configured to temporarily attach attachmentmembers/sutures to and to drive through the stomach tissues) aredeployed from end effector 250E1 to drive attachment members/sutures 104through the material 230 and stomach tissues as shown in FIG. 5I. Sutureanchors 106 are removably held in end effector 250E2 and are alignedwith the piercing members/suture drivers 102. Attachment members/sutures104 are releasably engaged with piercing members/suture drivers 102.Upon withdrawal of the piercing members/suture drivers, the proximalends of the suture mates 108P are retained by the anchors 106 and thesuture mates 108 slide off the piercing members/suture drivers 102,thereby leaving the suture mates 108 and attachment members/sutures 104installed through the tissues and material 230 as illustrated in FIG.5J. It is noted here that if the optional rotation is performed in FIG.5F′, then the instrument is counter-rotated by the amount about thelongitudinal axis thereof, to return the stomach 3 to the orientationshown in FIG. 5G, FIG. 5H, FIG. 5I or FIG. 5J, after performing theprocedures described above with regard to FIG. 5G or after performingthe procedures described above with regard to FIG. 5H, or afterperforming the procedures described above with regard to FIG. 5I, orafter performing the procedures described above with regard to FIG. 5J.

Attachment members/sutures 104 are also pre-installed through suturelocks 110 that are removably mounted on end effector 250E1 and aremounted on attachment members/sutures 104 proximal to the piercingmembers/suture drivers 102. Once the attachment members/sutures havebeen driven and anchored as illustrated in FIG. 5I and the stomach 3 hasbeen rotated back to its original orientation, if applicable,instruments 250 and 200 are removed from the patient, leaving theattachment members/sutures 104, suture locks 110, material 230, sutureanchors 106 and suture anchor mates 108 in place as illustrated in FIG.5J. Suture locks 110 have a one-way locking mechanism, such as aratcheting type mechanism or other arrangement such as directionallyoriented teeth that allow suture 104 to be pulled proximallytherethrough, but which prevent attachment members/sutures 104 frombacksliding distally therethrough. At FIG. 5K, the attachmentmembers/sutures 104 are cinched by pulling them proximally relative tothe suture locks 110 until a desired amount of tension is developed inthe attachment members/sutures 104, as described previously. Cinchingcan be performed by the use of laparoscopic graspers (not shown), forexample. The bougie 50 can then be removed from the patient and thepatient can be closed, according to known techniques, to complete theprocedure.

As a further option, an expandable implant 10 may be implanted to fillthe inside of the plication 3PL as illustrated in FIG. 5L. The implant10 may be a silicone bladder, for example, capable of being inflated bybiocompatible fluid such as liquid, gas, or a combination of fluids(gases, liquids, or liquids and gases). Implant 10 is connected via filltubing 12 in fluid communication with a subcutaneous fill port 80, sothat the fill volume of implant 10 can be adjusted after implanting itas described from a location outside of the abdominal cavity (e.g., byan operator accessing the subcutaneous fill port 80 with a needle aloneor a needle attached to a pressurized source of fluid). Other implants10 may be substituted, but need to be expandable and are preferablycontrollable as to amount of expansion. A tab or wing 11, 11′, 11″, 11″′may be provided to extend from the expandable body of the implant 10 andcan be inserted between the tissue folds at the plication suture line sothat the attachment members/sutures 104 are also installed through thetab or wing 11, 11′, 11″, 11″′ to thereby securely hold the implant inplace, as illustrated in FIG. 5L. The tab or wing 11, 11′, 11″, 11″′ maybe made of a mesh-reinforced silicone, for example. Alternatively, theimplant 10 may be fixed in place by connecting only to the superior andinferior ends of the plication suture line, or by connecting to one ormore of the suture locks 110 and/or suture anchors 106.

FIGS. 5M-5R schematically illustrate an alternative embodiment to theinstrumentation used in FIGS. 5A-5L, according to another embodiment ofthe present invention. In this embodiment, like the embodiment of FIGS.5A-5L, the procedures shown are laparoscopic procedures in which portsare installed in a patient for access to the abdominal cavity by notonly the instruments shown, but also by other instruments typically usedin laparoscopic surgery, such as graspers, endoscope, etc. Afterestablishing ports/pathway into the abdominal cavity from outside thepatient, the omentum 5 and connective tissues are dissected at thegreater curve 3G of the stomach 3 to provide access thereto, the same asin FIGS. 5A-5B. A bougie 50 is inserted trans-esophageally and placed inthe stomach 3 in a position such as shown in FIG. 5C. Typically thebougie 50 occupies a pathway extending naturally from the esophagus,through the stomach 3 and into the pylorus 3P, so as to occupy a spacesimilar to what is defined when a sleeve gastrectomy is performed. Thebougie 50 acts as a guide so as to better standardize the size(s) andlocation(s) of plication(s) formed by the procedure as well as toprevent reducing the stomach too aggressively, so as to ensure noblockage locations are inadvertently formed.

In the embodiment of FIGS. 5M-5R, engagement instrument 200′ (which,like engagement instrument 200 may optionally include secondary,mechanical clamping capability as discussed in more detail below) isconfigured like instrument 200, except the cross-sectional geometry ofend effector 200E′ is more compact than end effector 200E (when endeffectors 200E1 and 200E2 are closed together), circular as shown, butcould be oval, elliptical or other more compact cross-sectional geometrythan that of instrument 200, as can be observed by comparing FIG. 5Mwith FIG. 5D. This more compact cross-sectional configuration isdesigned to permit the end effector 200E′ to be inserted through arelatively smaller diameter port, such as a relatively smallerlaparoscopic port. In one embodiment, the cross-sectional configurationof end effector 200E′ is configured to enable the end effector 200E′ tobe passed through a laparoscopic port having a 15 mm inside diameter.The present invention is not limited to this dimension, as it is only anexample, and larger or smaller end effectors 200E′ may be provided.

Like instrument 200, instrument 200′ does not include piercingmembers/suture drivers 102, attachment members/sutures 104, anchors 106,anchor mates 108, suture locks 110 or any the actuation mechanisms fordriving and attaching attachment members/sutures. However, suction ports112 are provided in both end effectors 200E1′, 200E2′ and may be in thesame manner as in 200 and connection/joint mechanism 118 may be providedto function in the same manner. Also included are shaft 120 (not shown),handle 114 (not shown) and suction line 116 (not shown) all of which maybe the same is in instrument 200.

Stitching instrument 250′ is configured like instrument 250 except thecross-sectional geometry of the end effector 250E′ is more compact thanthat of end effector 250E, circular as shown, but with a cutout regiondesigned to be placed over the end effectors 200E1′, 200E2′ as describedbelow, but could be oval, elliptical or other more compactcross-sectional geometry while still retaining the cutout region 252, ascan be observed by comparing FIG. 5O with FIG. 5G. This more compactcross-sectional configuration is designed to permit the end effector250E′ to be inserted through a relatively smaller diameter trocarcannula, such as a laparoscopic trocar cannula. In one embodiment, thecross-sectional configuration of end effector 250E′ is configured toenable the end effector 250E′ to be passed through a laparoscopic trocarcannula having a 15 mm inside diameter. The present invention is notlimited to this dimension, as it is only an example, and larger orsmaller end effectors 250E′ may be provided.

Engagement instrument 200′ is inserted into the abdominal cavity and aworking end thereof is positioned over a location on the stomach 3 wherea plication line 3PL is intended to be formed, like in FIG. 5D. Theworking end is the distal end portion of the instrument 200′ andincludes a first end effector 200E1′ and a second end effector 200E2′extending alongside and opposing first end effector 200E1′, e.g., seeFIG. 5N. One of the end effectors 200E1, 200E2 is placed on a posteriorsurface of the stomach 3 and the other is placed on an anterior surfaceof the stomach 3 along a line opposed to a line of the posterior surfacethat the first end effector contacts. As with instrument 200, endeffector 200E1 can be contacted to the anterior surface of the stomach3, and end effector 200E2′ can be contacted to the posterior surface.Alternatively, end effector 200E1′ could be contacted to the posteriorsurface, and end effector 200E2′ could be contacted to the anteriorsurface.

The end effectors 200E1′, 200E2′ engage the surfaces of the stomach 3that they are contacted to by application of negative pressure throughsuction ports defined in the contact surfaces of the end effectors, inthe same manner as in instrument 200. The engagement forces aresufficiently strong so that when the end effectors 200E1′, 200E2′ areseparated (moved away from one another, similar to what is shown in FIG.5E), the portions of the stomach wall engaged by the end effectors arealso drawn apart, thereby expanding the interior volume within thestomach 3. As already noted, instrument 200′, like instrument 200 mayoptionally include secondary mechanical clamping of the stomach tissue 3to reinforce the strength of engagement of the end effectors with thestomach tissues, further ensuring that the tissues do not prematurelyseparate from the end effectors.

Next, a portion of the stomach forming at least a portion of the greatercurvature 3G is plicated (i.e., tucked) into the gap 200G formed byseparating the end effectors 200E1′, 200E2′, like what is shown in FIG.5F. The plicated portion of the stomach 3 is folded to an extent that itis located on the opposite side of the intended plication line, relativeto its pre-plicated location, as can be observed by comparing FIG. 5Ewith FIG. 5F. Optionally, but preferably, prior to plicating the portionof the stomach 3, the operator of the instrument 200′ may rotate theinstrument 200′ by about ninety degrees (counterclockwise, like theembodiment shown in the optional step of FIG. 5F′) about itslongitudinal axis. This option positions the stomach 3 to allow gravityto assist in plicating the portion 3G through the gap 200G, making theplicating much easier as the portion 3G “falls” in through gap 200G.

Once the portion 3G has been folded appropriately according to eitheroptional technique described above, the instrument 200′ is then operatedto move the end effectors 200E1′, 200E2′ together again thereby closingthe plication 3PL as schematically illustrated in FIGS. 5M-5N (distalend view and perspective view, respectively). Optionally the surgeon canuse a standard laparoscopic needle driver and needle with sutureattached thereto, to suture the plication manually by performing a lineof interrupted sutures through slots 200S. Alternatively, instrument250′ is mounted over the folded tissue layers of the plication andinstrument 200′ as illustrated in FIGS. 5O-5P (distal end view andperspective view, respectively) so that third end effector 250E1′ andfourth end effector 250E2′ contact and overlie the end effectors 200E1′and 200E2′, respectively. End effectors 200E1′, 200E2′ fit in the cutoutregion 252 of end effector 250E′. Optionally, a layer of material may bemounted in instrument 250′ (not shown in FIGS. 5M-5R, but like thatshown in FIG. 5G) to wrap around from the operational surface of endeffector 250E1′ to the operational surface of end effector 250E2′ (seeFIG. 5G) and to overlie the locations of the operational surfaces wherethe piercing members/suture drivers are driven out from, as well as thelocations where the suture anchors are removably mounted. By mounting asdescribed, the piercing members/suture drivers 102′ are aligned withslots 200S so that they can be rotationally driven out of end effector250E1′, through tissues 3 (and optionally material 230) and into endeffector 250E2′ where sutures 104 are anchored to anchors 106′ viasuture mate 108′ in much the same manner as described above with regardto FIGS. 5H-5I except that the driving is rotational rather than linear.This permits the end effectors to be made more compact and able to bedelivered through relatively smaller ports. FIGS. 5Q-5R schematicallyillustrate (distal end schematic representation and perspectiveschematic representation, respectively) piercing members/suture drivers102′ (preferably curved needles, but could alternately be screw drivesor other elongated members configured to temporarily attach attachmentmembers/sutures to and to drive through the stomach tissues) aredeployed from end effector 250E1′ to drive attachment members/sutures104 through the stomach tissues 3 (and, optionally, material 230).Instrument 250′ is operated to attach the folded tissue surfaces of thestomach 3 together in serosa-to-serosa contact to hold the plication. Atthe same time the layer of material 230, if used, is loosely attached tothe plication. Material 230 forms a barrier layer that spans the sutureline to prevent herniation of the plicated stomach in between theattachment members/sutures, thereby greatly reducing the risk ofischemia. The barrier material may be a sheet or strip of silicone, withor without mesh reinforcement, for example. Whether or not reinforced,the exterior of the strip is silicone, to prevent tissue ingrowth. Bypreventing tissue ingrowth, this will facilitate reversal of theprocedure/plication as the silicone strip will be easily removable.

Suture anchors 106′ are removably held in end effector 250E2′ and arealigned with the piercing members/suture drivers 102′. Attachmentmembers/sutures 104 are releasably engaged with piercing members/suturedrivers 102′. Upon withdrawal of the piercing members/suture drivers,the proximal ends of the suture mates are retained by the anchors 106′and the suture mates 108′ slide off the piercing members/suture drivers102, thereby leaving the suture mates 108′ and attachmentmembers/sutures 104 installed through the tissues and optionally, thematerial 230. It is noted here that if the optional rotation isperformed in FIG. 5F′, then the instrument(s) is/are counter-rotated bythe amount about the longitudinal axis thereof, to return the stomach 3to the orientation shown in FIG. 5G, FIG. 5H, FIG. 5I or FIG. 5J, afterperforming the procedures described above in FIG. 5N or after performingthe procedures described above in FIG. 5P, or after performing theprocedures described above in FIG. 5R, or after performing theprocedures described above like in FIG. 5J.

Attachment members/sutures 104 are also pre-installed through suturelocks 110 (like those shown in FIGS. 5I-5J) that are removably mountedon end effector 250E1′ and are mounted on attachment members/sutures 104proximal to the piercing members/suture drivers 102′. Once theattachment members/sutures have been driven and anchored as illustratedin FIG. 5R and the stomach 3 has been rotated back to its originalorientation, if applicable, instruments 250′ and 200′ are removed fromthe patient, leaving the attachment members/sutures 104, suture locks110, (optionally, material 230), suture anchors 106′ and suture anchormates 108′ in place like what is shown in FIG. 5J. Suture locks 110 havea one-way locking mechanism, such as a ratcheting type mechanism orother arrangement such as directionally oriented teeth that allow suture104 to be pulled proximally therethrough, but which prevent attachmentmembers/sutures 104 from backsliding distally therethrough. Like shownin FIG. 5K, the attachment members/sutures 104 are cinched by pullingthem proximally relative to the suture locks 110 until a desired amountof tension is developed in the attachment members/sutures 104, asdescribed previously. Cinching can be performed by the use oflaparoscopic graspers (not shown), for example. The bougie 50 can thenbe removed from the patient and the patient can be closed, according toknown techniques, to complete the procedure.

As a further option, an expandable implant 10 may be implanted to fillthe inside of the plication 3PL in a manner like that shown in FIG. 5L.The implant 10 may be a silicone bladder, for example, capable of beinginflated by biocompatible fluid such as liquid, gas, or a combination offluids (gases, liquids, or liquids and gases). Implant 10 is connectedvia fill tubing 12 in fluid communication with a subcutaneous fill port80, so that the fill volume of implant 10 can be adjusted afterimplanting it as described from a location outside of the abdominalcavity (e.g., by an operator accessing the subcutaneous fill port 80with a needle alone or a needle attached to a pressurized source offluid). Other implants 10 may be substituted, but need to be expandableand are preferably controllable as to amount of expansion. A tab or wing11, 11′, 11″, 11″′ may be provided to extend from the expandable body ofthe implant 10 and can be inserted between the tissue folds at theplication suture line so that the attachment members/sutures 104 arealso installed through the tab or wing 11, 11′, 11″, 11″′ to therebysecurely hold the implant in place, like that illustrated in FIG. 5L.The tab or wing 11, 11′, 11″, 11″′ may be made of a mesh-reinforcedsilicone, for example. Alternatively, the implant 10 may be fixed inplace by connecting only to the superior and inferior ends of theplication suture line, or by connecting to one or more of the suturelocks 110 and/or suture anchors 106.

An alternative embodiment to those shown in FIGS. 5M-5R is one where thedevice 250′ deploys a continuous suture instead of multiple interruptedsutures. In this embodiment, the device 250′ would deploy a needledriver that moves from one suture slot 200S to the next, through ahelical motion or through a series of alternating rotation and advancingmotions. This method of suturing would result in a continuous suturethat penetrated the stomach tissue at each location inside the slots200S.

Another alternative embodiment to those shown in FIGS. 5M-5R is onewhere the suction and suturing functionalities of the two instrumentsare combined into one instrument. This embodiment would be similar tothe embodiment of FIGS. 2D-2H in that the suction and suturingfunctionalities are provided in a single instrument. However, thisembodiment may also be similar to those of FIGS. 5M-5R in that it mayutilize needles that have a curved shape, rather than the straightneedles shown in FIGS. 2D-2H. In this manner, the curved needles may behoused within the upper end effector, with the suture anchors 106 beinghoused in the lower end effector. The suction features would be presentin both the upper and lower end effectors. As described for FIGS. 2D-2H,the end effectors would close onto the stomach, grip the stomach withsuction, open and spread the walls of the stomach, imbricate the stomachand close. At this point, the curved needles would advance through thetissue, being driven by a cam mechanism, a gear, or another drivingmechanism. The needles would rotate so that their curved shapes advancethrough the stomach tissue, engaging the suture anchor mates 108 withthe suture anchors 106 housed in the lower end effector. This embodimentmay have an advantage over that of FIGS. 2D-2H because the curved shapeof the needles, with the rotating advancement, may enable the suturingfunctionality to be miniaturized into a smaller end effector 9 ascompared to the straight needles of FIGS. 2D-2H), which can be usedthrough a smaller surgical port. This embodiment may have an advantageover the embodiments of FIGS. 5m -5R because it can be used through asingle surgical port instead of two ports.

FIG. 6 is a partial perspective view of a bougie 50′ that can be used inany of the procedures described herein that employ bougie 50,alternatively to the use of bougie 50, according to an embodiment of thepresent invention. Bougie 50′ has the same outside diameter as that ofbougie 50, typically 32 French, but could vary, in the same mannerdescribed above with regard to bougie 50. Bougie 50′ is provided with around cross-section and is flexible in bending along its length, butrelatively rigid under compression along its longitudinal directionwhich facilitated insertion through the esophagus and into the stomach.Bougie 50′ is provided with a blunt, atraumatic distal tip 52 withbluntness provided by the curvature of the distal end of the tip 52.Bougie 50′ includes an elongated, flexible tube 54 that has a flexibleportion at least its distal end portion (excluding distal tip 532),which flexible portion is long enough to extend out of the mouth of thepatient when the bougie 50′ has been placed in its intended operativelocation (e.g., when tip 52 is at the location of the pylorus asdescribed above). when in an unreinforced configuration, as illustratedin FIG. 1A. Tube 54 may be formed of polyvinyl chloride (PVC) to ensurethat the tube is transparent for maximizing visualization via anendoscope 33 that is insertable therein (shown in phantom in FIG. 6).Alternatively, polyethylene, polyurethane, PEBAX or MILIFLEX®(thermoplastic elastomer, thermoplastic olefin, Melitek, Dusseldorf,Germany) may be used. Optionally a proximal portion 56 that remainsoutside of the patient during use may be made stiff or relatively rigidto aid in manipulation of the bougie 50′.

One advantage of this embodiment is that a flexible endoscope 33 can beinserted into bougie 50′ to provide visibility to a user outside thepatient, through the clear walls of tube 54 and tip 52. Flexibleendoscope 33 can be advanced up into the flexible distal portion ofbougie 50′ to provide views along a curved pathway of a tract in thestomach being formed by a procedure according to an embodiment of thepresent invention. Thus bougie 50′ enables appropriate sizing of thestomach lumen formed during a plication procedure. Additionally,visualization can be performed through the clear side walls and tip ofbougie 50′ to inspect the sizing of the stomach lumen and/or variousintermediate stages of performing the plication, from a location insidethe stomach 30. Further details about various embodiment of bougie 50′can be found in co-pending application Ser. No. 12/474,118 filed May 28,2009 and titled “Devices, Systems and methods for Minimally InvasiveAbdominal Surgical Procedures”, which application is hereby incorporatedherein, in its entirety, by reference thereto.

Referring now to FIGS. 7A-7I, various events are illustrated for theperformance of a procedure in which a device 10 is implanted withinplications formed at external locations of the stomach. The procedureshown in FIGS. 7A-7I is a laparoscopic procedure in which ports areinstalled in a patient for access to the abdominal cavity by not onlythe instrument shown, but also by other instruments typically used inlaparoscopic surgery, such as graspers, endoscope, etc.

After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve of the stomach to provide access thereto, see FIGS. 7A-7B.A bougie 50 is inserted trans-esophageally and placed in the stomach 3in a position such as shown in FIG. 7C. Typically the bougie occupies apathway extending naturally from the esophagus, through the stomach 3and into the pylorus 3P, so as to occupy a space similar to what isdefined when a sleeve gastrectomy is performed. The bougie acts as aguide so as to better standardize the sizes and locations of plicationsformed by the procedure as well as to prevent reducing the stomach tooaggressively, so as to ensure no blockage locations are inadvertentlyformed.

An attachment instrument 300 is inserted into the abdominal cavity andan end effector 300E formed on a distal end of the instrument 300 andhaving an implantable device 10 releasably mounted thereto, is contactedto the stomach 3 in a manner as illustrated in FIG. 7D, such that thedevice 10 contacts the external wall of the stomach 3 and is positionedbetween the stomach 3 and the end effector 300E. As shown in FIG. 7D,the end effector is oriented so that the device 10 primarily contactsthe body 3B and fundus 3F of the stomach, while the bougie 50 helpsinsure that the cardia 3C, pylorus 3P and pyloric antrum 3PA remain openso as to avoid risk of forming blockages. Once the end effector 300E hasbeen oriented so that it is substantially aligned with the central,substantially straight section of the bougie 50 (see FIG. 7D), tissuepins 302 are deployed so as to extend from the surface of the endeffector 300E as shown in FIG. 7E.

Next, at FIG. 7F, graspers are used to grasp portions of the stomach 3and fold the portions over each side of the end effector 300E, pushingthe stomach plications 3PL onto the tissue pins 302 so as to temporarilyhold the plications 3PL in the positions shown in FIG. 7F. At FIG. 7G, astrap 304 of the attachment instrument 300 is inserted through the sameport that the end effector 300E was inserted through. The distal endportion 304D of the strap 304 is connected to the distal and proximalends of the end effector 300E. The strap 304 is mounted on a stiffpaddle and the paddle is used to hold the strap 304 in place incompression against the stomach plications 3PL as shown. The paddleincludes a proximal handle 304H that extends out of the patient and isused by the operator to manually adjust the clamping force of the straponto the tissue so as to hold the tissue of the plications 3PL in tightapproximation to the end effector 300E. Stitching needles are thendeployed from the end effector 300E to penetrate the double walls of thestomach plications 3PL and connect suture bullets (described below) toanchors 32 (such as speed nuts, traps or other features that aredirectly connectable to the suture bullets). The opposite ends of theattachment members/sutures 30 are pre-fixed to a layer of material 12that encourage tissue ingrowth and is also fixed to the expandabledevice 10, see FIG. 7I. For example, the tissue ingrowth encouragingmaterial may be a porous mesh of biocompatible material such as DACRON®(polyester) or other fabrics that are known in the art to encouragetissue ingrowth. The attachment members/sutures are tightened and bougie50 and attachment instrument 300 (including the strap 304 are removed,as shown in FIG. 7H, leaving the device 10 in place, maintained inpositioning by the plications (see FIG. 7H) which are sutured to thedevice 10 via attachment members/sutures 30, see FIG. 7I. The plications3PL preferably abut one another in serosa-to-serosa contact asillustrated by 3S2S in FIGS. 7H-7I. The space left by removal of the endeffector 300E provides room for the device 10 to expand into. As shownin the cross-section illustration of FIG. 7I, device 10 can then beexpanded/inflated to further reduce the amount of space in the interiorcavity of the stomach 3. The sleeve volume gauged by placement of thebougie 50 during the procedure can be adjusted by adjusting the volumeof the device 10. The fill tube 12 is connected to an access devicewhich can be implanted outside the abdominal cavity, against theexternal abdominal wall or fascia, for example, as described inapplication Ser. Nos. 11/407,701; 11/881,144; 10/567,199; 11/974,444;11/716,985; 11/716,986; 12/473,818; 12/473,881; 12/474,118; 12/474,070;12/474,087; 12/474,158; 12/474,234; 12/474,251; 12/474,253; 12/474,226;and 13/015,086, each of which is hereby incorporated herein, in itsentirety, by reference thereto.

The implantable devices described herein are preferably cylindricalshaped, so as to form a rod or hot-dog-like appearance, but could be ofanother shape, including, but not limited to a curved, cylindrical shapenot unlike the shape of a banana. The devices are expandable, typicallyby input of a pressurized fluid, such as saline or other biocompatibleliquid, biocompatible gas, or a combination of biocompatible gas andliquid.

FIG. 8A is a perspective view of another embodiment of an attachmentinstrument according to the present invention, configured to be operatedfrom outside of a patient, with the end effector having been insertedthrough a laparoscopic port or percutaneous opening and into contactwith the patient's stomach 3 (e.g., into the abdominal cavity of thepatient), and to reduce the effective volume of the stomach 3 byperforming one or more plication procedures on it.

Attachment instrument 400 includes an elongate end effector 400E havinga length 400L greater than a width 400W (typically at least more thantwice as great) formed at a distal end portion of instrument 400. Endeffector 400E includes a distal end 400D, a proximal end 400P and firstand second sides 400S. An elongate shaft 420 extends proximally from theproximal end 400P of end effector 400E. Shaft 420 has sufficient lengthso that a proximal end of the shaft 420 extends out of the patient'sbody when the end effector 400E is placed on the patient's stomach in amanner described below and shown in FIG. 8D.

A plurality of piercing members 102 (typically suture drivers such asstitching needles or the like) are positioned along a pair of rowsextending lengthwise along the end effector 400E, one row along eachside 400S (e.g., see sectional illustration of FIG. 8N). A portion of arow is shown in the enlarged partial view of FIG. 8O that shows threepiercing members 102.

A plurality of attachment members 104 extend along a pair of rowsextending lengthwise along the end effector 400E, see FIGS. 8B, 8F, 8I,8J, 8M and 8O. The attachment members shown in this embodiment areattachment members/sutures 104 and are arranged, configured andpositioned to be driven through a fold in the stomach 3.

A lower contact plate 402 is spaced beneath and parallel with an uppertissue contact surface 404 of the end effector 400E, forming a gap 400Gbetween plate 402 and surface 404 as shown in FIG. 8B. A drivingmechanism 410 is provided which is configured to drive folds of stomachtissue into the gap 400G between plate 402 and surface 404. As shown inFIGS. 8A, 8B and 8E, driving mechanism 410 includes a pair ofmechanisms, one on each side, each including a pair of textured rollerbars 412, gears configured for selectively operating a single roller 412or the pair of roller bars in linked unison, and a driver 416, which maybe hand operation of one or more shafts extending proximally from thegears or one or more motors for operating the roller bars 412. Theroller bars 412 extend lengthwise along the end effector 400E, onealongside surface 404 and one alongside plate 402 and, when operated,are rotated counter to each other so as to either pull tissue in betweenthe bars 412 or eject tissue out from the gap 400G between the bars. Theopposite side 400S is configured with a mechanism that is the same asthat described and shown in FIG. 8B. The pair of mechanisms typicallyoperate the pairs of rollers 412 on opposite sides independently of eachother. Optionally, the mechanisms may be selectively linked to controlboth sets of rollers to perform the same operation simultaneously(taking tissue in or driving tissue out).

A handle 430 is connected to a proximal end portion of shaft 420. Shaft420 has a length sufficient to allow a user to operate the controls onhandle 430 (and the drive shafts 417 at least when the driver 416 ishand operation) from a location outside of an obese or overweightpatient when the end effector 400E has been contacted to the stomach ina manner as shown in FIG. 8D. Handle 430 includes an axial portion 430Aand a transverse portion 430T, see FIGS. 8A and 8C. These portions areconfigured so that the user can apply both hands to the handle 430 ifdesired and, by pushing on handle portion 430T and pulling up on handleportion 430A can apply a force to the end effector 400E to press it downagainst an external surface of the stomach 3 where the plicationprocedure is to be performed. Plate 402 is biased away from surface 404such as by coil springs 422 or the like, so that gap 400G is maintaineduntil actuator 440 is engaged (such as by pressing with the thumb, inthe embodiment shown), which causes plate 402 and surface 404 to bedriven closer together, so as to clamp down on stomach tissues after thestomach tissues have been drawn into the gap 400G sufficiently.

After preparing the patient, inserting a bougie 50, 50′ into the stomach3 in a manner as described above and forming either a percutaneousopening (e.g., puncture and opening leading from puncture into theabdominal cavity, for a percutaneous procedure) or a plurality of portsfor a laparoscopic procedure, end effector 400E of instrument 400 isinserted through the puncture or one of the ports and delivered into theabdominal cavity, where it is placed into contact with an exteriorsurface of the stomach 3 as shown in FIG. 8D. Typically, the endeffector is substantially aligned with the bougie 50, 50′ adjacent tothe bougie 50, 50′ on a location of the stomach nearer to the greatercurvature 3G or on the greater curvature 3G with the bougie 50, 50′being nearer the lesser curvature 3L as shown. End effector 400Epreferably contacts the stomach 3 in an inferior to superior directionextending substantially over the body 3B and fundus 3F, but not over orin contact with the pylorus 3P, pyloric antrum 3PA, cardia 3C orgastroesophageal junction 3GE.

Once the end effector 400E has been properly positioned as intended andcontacted to the stomach 3, as illustrated in the schematiccross-sectional view of FIG. 8E, the bougie 50, 50′ is removed from thepatient and the roller bars 412 are operated by operating the drivingmechanisms to draw stomach tissue into the gap 400G on both sides 400Sof the end effector as illustrated in FIGS. 8F-8G. Optionally,conventional laparoscopic graspers can be used to initially feed thestomach tissue into the gap. The plications of tissue formed are pulledover the lower roller bars 412 and under the upper roller bars 412 asshown best in the schematic, cross-sectional illustration of FIG. 8G.Vacuum tubes 442 are provided that extend along the upper surface ofbase 402 and are provided with ports or openings at intervals along thelengths thereof. Vacuum tubes 442 extend parallel to roller bars and toeach other, but are located adjacent to the central longitudinal axis ofbase 402 as illustrated in FIG. 8G. Preferably, a pair of vacuum tubes442 are provided, one on each side of the central longitudinal axis asshown, although more or fewer vacuum tubes 442 may be employed. Vacuumdelivered through the openings/ports of the vacuum tubes 442 hold theplicated tissues in contact therewith once the plicated tissues havebeen drawn/driven into contact therewith by the driving mechanism.Vacuum tubes 442 may additionally assist in drawing the tissues into thefinal positions shown in FIG. 8G. As noted previously, the operator canturn the roller bars 412 to draw stomach tissue into the positions shownin FIG. 8G in preparation for stitching. The bars 412 are textured orprovided with other features to assist gripping the stomach tissue. Thebars 412 can be rolled together or individually, in order to providegreater control over how the tissue is drawn into the gap 400G.

At this time, the operator operates actuator 440 to clamp the stomachtissue in the end effector 400E. In the unactuated position of actuator440 shown on the left side of FIG. 8H, the gap 400G is in its biasedopen position as illustrated in FIG. 8I. Upon operating the actuator 440to the actuated position shown on the right side of FIG. 8H, the plate402 and surface 404 are brought closer together, thereby clamping thetissue in accordance with the force arrows shown in FIG. 8J.

Once the stomach tissues have been clamped as described above, stitchingactuator 442 is next actuated to drive piercing members 102 andattachment members 104 through the stomach tissues as illustrated inFIGS. 8M, 8N and 8O. Piercing members 102 are preferably needles, butcould alternately be screw drives or other elongated members configuredto temporarily attach attachment members thereto and to drive throughthe stomach tissues. Attachment members 104 are preferably sutures, butcould alternatively be ribbons or other attachment members configured toperform as described, or hybrids thereof. Suture anchors 106 (best shownin FIG. 8B) are removably held in plate 402 and are aligned with thepiercing members/suture drivers 102. Attachment members (which aresutures, in the embodiment shown) 104 are releasably engaged withpiercing members 102. In the embodiment shown in FIG. 8O, attachmentmembers/sutures 104 are each provided with an anchor mate 108 on adistal end portion thereof, preferably at the distal end thereof. Anchormate 108 is configured to slide over the tapered distal end portion ofthe suture driver/stitching needle 102, but is prevented from slidingfurther proximally by the increasing diameter of the taper of thedriver/needle 102 distal end portion. The exterior of the anchor mate108 is also tapered, so that the distal end 108D thereof is of a smallercross-sectional dimension than the proximal end 108P thereof. Thisfacilitates the driving of the anchor mate 108 into the anchor 106 asshown in FIG. 8N. However, upon withdrawal of the piercing member 102,the proximal end of the anchor mate 108P is retained by the anchor 106and the anchor mate 108 slides off the piercing member/suture driver102, thereby leaving the anchor mate 108 and suture 104 installedthrough the tissues as illustrated in FIG. 8P. In the embodiment shown,actuator 442 is biased to the position shown at the top of FIG. 8L andfunctions as a ratchet during actuation such that cycling the actuatorbetween the position shown at the top and the position shown at thebottom of FIG. 8I incrementally drives the piercing members 102, anchormates 108 and attachment members 104 through the tissues and into theanchors 106 where anchors 106 and attachment members 104 are retained.Continued cycling retracts the piercing members 102 back into the mainbody of the end effector 400E into the stowed positions were they areconcealed.

The end effector 400E is then removed by sliding it out of the attachedtissues, whereby anchors 106 release from plate 402, leaving anchormates 108, and therefore also attachment members/sutures 104 inretention by anchors 106 as shown in FIG. 8P. Attachment members/sutures104 are also pre-installed through suture locks 110 that are attached toa conjunction member 460. In the embodiment shown in FIG. 8P, side byside pairs of sutures are preinstalled through suture locks,respectively (although other alternative arrangements may besubstituted, including, but not limited to providing a suture lock 110for each suture 104 as illustrated in the variant shown in thecross-sectional illustration of FIG. 8S) and conjunction member 460 isprovided as a strip of material having sufficient length and width tocover the plication line 3PL formed by the abutment of the two tissuefolds of stomach. Conjunction member 460 is configured as a porousmaterial on the side 460B facing the plication line 3PL (see FIG. 8Q).The porous material is a tissue ingrowth material that may be made ofany of the same materials mentioned above with regard to tissue ingrowthmaterials and/or any known biocompatible tissue ingrowth materialssuitable for accomplishing the tasks described. The opposite side 460Tof the conjunction member, which faces away from the plication line 3PL(see FIG. 8P) is nonporous to prevent tissue ingrowth therein. Forexample, the top surface 460T of 460 in FIG. 8P may be formed or coatedwith silicone or other nonporous biocompatible substance to preventtissue ingrowth into the top surface of the conjunction member 460.

Suture locks 110 have a one-way locking mechanism per each attachmentmember/suture 104 inserted therethrough, such as a ratcheting typemechanism or other arrangement such as directionally oriented teeth thatallow attachment member/suture 104 to be pulled proximally therethrough,but which prevent attachment members/sutures 104 from backslidingdistally therethrough. FIGS. 8R and 8S illustrate the pulling ofattachment members/sutures 104 in tension in the directions indicated bythe arrows, so that they slide proximally relative to suture locks 110,thereby cinching the attachment members 104 tight under tension andbringing the conjunction member 460 into contact with the stomachtissues so as to overlie the plication line 3PL as illustrated in FIG.8R. As a result, the folds of the two plications are drawn into abutmentif they were not already in abutment, and the plication line 3PL ismaintained with the folds in abutment, in serosa-to-serosa contact, byanchors 106 and anchor mates 108 underneath and conjunction member 460and suture locks 110 on top, interconnected under tension by attachmentmembers/sutures 104. Because the width of the conjunction member 460 andespecially the width of the suture lock 110 or side by side pair ofsuture locks is less than the width 106W of the original spacing betweenanchors 106 (see FIG. 8P), the cinching of the attachmentmembers/sutures 104 described above causes the stomach tissue to bedrawn toward the center line, driving the opposing tissue folds togetherin abutment, providing serosa-to-serosa contact which eventually adhereto each other and grow together. The outer surfaces of the stomachcontacting surface 460B will also grow into the tissue ingrowth materialthereof. These two tissue joints (serosa-to-serosa adhesion and tissueingrowth into the mesh 460B) provide long term attachment that maintainsthe plication in the configuration illustrated in FIGS. 8R and 8S.

FIG. 9 is a schematic illustration of an alternative mechanism formaking a stitch (or simultaneous stitches) through tissue that isapplicable to stitching a plication line PL according to anotherembodiment of the present invention. In this embodiment, piercingmembers/stitching needles 102 are rotationally driven out of the surfaceof the end effector 400E′ through tissue and into engagement with anattachment member/suture anchor 106. Tissue pins/stabilizing pins aredeployed at step 9A so as to temporarily hold the tissue in place duringthe stitching procedure. At 9B, deployment of the piercingmembers/stitching needles 102 from the surface of the end effector 400E′is begun, such as by use of an actuator like 442 described in regard toFIG. 8A, although not shown here. Further details about the structureand functioning of driving mechanisms and other components of thisembodiment can be found in co-pending application Ser. No. 12/474,226,which has already been incorporated herein, in its entirety, byreference thereto above. At 9B the piercing members/stitching needles102 are shown in an early stage of deployment of the process, e.g.,after only one or two pulls of the actuator 4172. Note that thelocations where the members/needles 102 pierce into the tissue 3 aresubstantially aligned with the locations where the correspondingstabilizing pins/tissue pins 302 pierce into the target. In theembodiment shown, the tip of the needle 102 is aligned axially (i.e., atthe same length along the proximal-distal axis of the stitchinginstrument, i.e., the left-right direction in 9B) with the tip of thestabilizing pin 302, when both are in their starting positions, ready topierce into tissue 5. Also, pins 302 are angled in a direction oppositeto a direction toward which the stitching needles 102 are angled,relative to the surface of the tissue 3, as they enter the tissue 3. Inthis way, the stabilizing pins/tissue pins 302 provide counter-tractionand prevent the tissue 3 from being dragged or bunched up or pushed awayby the stitching needles 102 as they sweep through the tissue 3, beingrotated into and then out of the tissue 3T.

At 9C, the piercing members/stitching needles 102 have been rotatedabout halfway through the tissue 3. Note that the pins 302 remain inposition as originally deployed. The piercing members/stitching needles102 have been rotated in 9D to the extent where the tips of the needles102 have emerged back out of the tissue 3. Like the tissuepins/stabilizing pins, the needles 102 may pass all the way through thetissue 3 (phantom lines) or may rather be inserted into the tissue 3,rotated through the tissue 3 without ever passing through a back side ofthe tissue 3, and pass back out of tissue 3 at another location (exitlocation) different from the entry location, but located on the samesurface of the target. This is preferred for serosa-to-serosa stitchingwhere it is desirable not to pass into the mucosa or interior of thestomach, but only through the serosa 3S and muscularis 3M layers. 9Eillustrates the needles 102 having been rotated to the extent where thetips of the needles 102 and the anchor mates 108 have been driventhrough the respective attachment member/suture anchors 106. Uponcounter-rotation of the needles 102, the tips of the needles 102 slideout of contact with the anchor mates 108 and pass back out of theattachment member/suture anchors 106, while the attachment member/sutureanchors 106 retain the anchor mates 108 and prevent them from passingback through, thereby securing the attachment members/sutures 104 to theattachment member/suture anchors 106.

Upon anchoring the attachment members/sutures 104 to the anchors 106 asdescribed above and when the piercing members/stitching needles 102 havebeen fully returned to their concealed positions in the end effector400E′, the tissue/stabilizing pins 302 can be retracted into theirconcealed positions within the end effector 400E′.

Instrument 400′ can therefore be used to perform a method for decreasingthe effective volume of a patient's stomach, to include contacting alength end effector 400E′ to an external surface of the stomach 3;forming a fold in the stomach and positioning the fold over a portion ofthe end effector; deploying the tissue/stabilizer pins 302 totemporarily hold the fold of tissue in place on the end effector 400E′;and simultaneously driving a plurality of attachment members 102 throughthe fold, wherein the attachment members are configured along a lengthdirection relative to the end effector 400E′. Optionally, a device 10 ofany of the types described above could be installed between an externalsurface of the stomach and the fold using the end effector 400E′ and/orother instrument. The instrument 400′ can be used to place a row ofstitches in a single deployment as described above to make a plicationand a reduced volume sleeve in the stomach, or can be used multipletimes to perform multiple deployments to form a sleeve in the stomach byinstalling multiple lines of stitches. In this and all other embodimentsemploying one or more attachment members/sutures 104, the attachmentmembers/sutures 104 may be sutures and may be connected at their distalends to anchor mates 108 as described above, which anchor mates 108 maybe made of plastic or metal. Alternatively, in addition to thealternatives already previously noted, attachment member/suture 104 maybe a metal wire or lead configured to connect with anchor 106, and thesemetal wires or leads may be similarly connected to metal or plasticanchor mates 108. Metal wire or lead 104 may or may not be electricallyconductive.

Instrument 400′ may alternatively be used intralumenally to stitch aplication inside the stomach 3 by driving the needles 102 through mucosaand back out of mucosa, after passing through one or more additionallayers of the stomach wall. Thus full penetration or partial penetrationof the stomach wall may be performed during stitching.

FIGS. 10A-10J illustrate various events for the performance of aprocedure in which a device 10 is implanted within plications formed atexternal locations of the stomach 3 according to an embodiment of thepresent invention. The procedure shown in FIGS. 10A-10J is alaparoscopic procedure in which ports are installed in a patient foraccess to the abdominal cavity by not only the instrument shown, butalso by other instruments typically used in laparoscopic surgery, suchas graspers, endoscope, etc.

After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve of the stomach to provide access thereto, the same asdescribed above with regard to FIGS. 7A-7B. A bougie 50, 50′ is insertedtrans-esophageally and placed in the stomach 3 in a position such asshown in FIG. 10A. Typically the bougie 50, 50′ occupies a pathwayextending naturally from the esophagus, through the stomach 3 and intothe pylorus 3P, so as to occupy a space similar to what is defined whena sleeve gastrectomy is performed. The bougie acts as a guide so as tobetter standardize the sizes and locations of plications formed by theprocedure as well as to prevent reducing the stomach 3 too aggressively,so as to ensure no blockage locations are inadvertently formed.

An attachment instrument 300′ is inserted into the abdominal cavity andan end effector 300E′ formed on a distal end of the instrument 300′ andhaving an implantable device 10 releasably mounted thereto, is contactedto the stomach 3 in a manner as illustrated in FIG. 10A, such that thedevice 10 contacts the external wall of the stomach 3 and is positionedbetween the stomach 3 and the end effector 300E′. As shown in FIG. 10A,the end effector 300E′ is oriented so that the device 10 primarilycontacts the body 3B and fundus 3F of the stomach, while the bougie 50,50′ helps insure that the cardia 3C, pylorus 3P and pyloric antrum 3PAremain open so as to avoid risk of forming blockages. Once the endeffector 300E′ has been oriented so that it is substantially alignedwith the central, substantially straight section of the bougie 50, 50′(see FIG. 10A), tissue pins/stabilizer pins 302 are deployed so as toextend from the surface of the end effector 300E′ as shown in FIG. 10B.

Next, at FIG. 10C, graspers or other instrument are used to graspportions of the stomach 3 and fold the portions over each side of theend effector 300E′, pushing the stomach plications 3PL onto the tissuepins 302 so as to temporarily hold the plications 3PL in the positionsshown in FIG. 10C. At FIG. 10D, conjunction member 460 is placed overthe line where the plications 3PL join one another, to cover thejunction line. This placement may be performed using graspers forexample, or other instrument(s). In the embodiment shown in FIG. 10D,conjunction member 460 is provided as a strip of material havingsufficient length and width to cover the plication line 3PL formed bythe abutment of the two tissue folds of stomach. Conjunction member 460is configured as a porous material on the side in contact with thestomach tissues and plication line 3PL (see FIG. 10D). The porousmaterial is a tissue ingrowth material that may be made of any of thesame materials mentioned above with regard to tissue ingrowth materialsand/or any known biocompatible tissue ingrowth materials suitable foraccomplishing the tasks described. The opposite side 460T of theconjunction member 460, which faces away from the plication line 3PL(see FIG. 10D) is nonporous to prevent tissue ingrowth therein. Forexample, the top surface 460T of 460 in FIG. 10D may be formed or coatedwith silicone or other nonporous biocompatible substance to preventtissue ingrowth into the top surface of the conjunction member 460.

At FIG. 10E, a strap 304′ of the attachment instrument 300′ is insertedthrough the same port that the end effector 300E′ was inserted through.The distal end portion 304D′ of the strap 304′ is connected to thedistal end portion 300D′ of the end effector 300E′ and the proximal endportion 304P′ is connected to the proximal end portion 300P′ of the endeffector 300E′ by means of a paddle that it is connected to. The paddleincludes a proximal handle 304H that extends out of the patient and isused by the operator to manually adjust the clamping force of the strap304 onto the tissue 3 to hold the conjunction member 460 and tissue 3 intight approximation to the end effector 300E′. Piercingmembers/stitching needles 102′ are then deployed from the end effector300E′ to penetrate the double walls of the stomach plications 3PL andthe conjunction member 460 and to connect anchors 108′ to theconjunction member 460, see FIG. 10F.

In the embodiment shown, piercing members/stitching needles 102′ areconfigured with a slot 102S that opens to the distal end of 102′ but isclosed at the proximal end of the slot 102S, see FIG. 10F′. Attachmentmembers/sutures 104 are attached distally to T-bars 108′ (see FIG. 10G).T-bar 108′ extends out of slot 1025 when attachment member/suture 104 ispreinstalled through the hollow lumen in piercing member/stitchingneedle 102′. When piercing members/stitching needles 102′ are deployed,they carry the T-bars 106′ and therefore also attachment members/sutures104 along with them, as the T-bars stop out against the closed ends ofthe slots 102S. The portion of the T-bar that extends out of the slot102S is driven through the tissue 3 and conjunction member 460. When thepiercing members/stitching needles 102′ are withdrawn back out of theconjunction member 460 (FIG. 10G), the extending portions of the T-bars106′ catch in the mesh of the conjunction member or other part of theconjunction member 460 and are passively deployed out of the needles102′ thereby anchoring themselves to the conjunction member 460 asillustrated in the sectional view of FIG. 10J. The opposite ends of theattachment members/sutures 104 are pre-fixed to a layer of material 12via suture locks 110. Material 12 encourages tissue ingrowth and is alsofixed to the expandable device 10, see 10J. For example, the tissueingrowth encouraging material may be a porous mesh of biocompatiblematerial such as DACRON® (polyester) or other fabrics that are known inthe art to encourage tissue ingrowth.

After completely retracting the needles 102′ back into the end effector300E′ at FIG. 10G, the tissue pins 302 are retracted at FIG. 10H andstrap 304 is detached and removed from the patient, leaving theconjunction member 460 attached to the tissues 3 as shown in FIG. 10H.Next, the bougie 50, 50′ is removed from the stomach 3 and the patientat FIG. 10I. The sutures 104 can then be cinched down under tension bypulling them through suture locks 110, and excess suture material canthen be trimmed, such as by using a suturing/stitching device asdescribed in application Ser. No. 12/474,226 or by use of graspers, forexample. The remaining instruments are then removed and the implant 10is inflated via inflation tubing 12. Inflation tubing is then connectedin fluid communication with an inflation port that allows changing thevolume of the implant from outside of the patient.

FIG. 10J is a cross-sectional illustration of the result of theprocedure described above, with implant 10 having been inflated. Thesleeve volume 3S can be adjusted by adjusting the volume of the implant10. The space 300SP left upon removal of the end effector 300E′ allowsfor room for the implant 10 to expand into upon further adjustment.

FIGS. 11A-11S illustrate various events for the performance of aprocedure in which a device 10 is implanted within plications formed atexternal locations of the stomach 3 according to an embodiment of thepresent invention. The procedure shown in FIGS. 11A-11S is alaparoscopic procedure in which ports are installed in a patient foraccess to the abdominal cavity by not only the instrument shown, butalso by other instruments typically used in laparoscopic surgery, suchas graspers, endoscope, etc.

After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve of the stomach to provide access thereto, the same asdescribed above with regard to FIGS. 7A-7B. A bougie 50, 50′ is insertedtrans-esophageally and placed in the stomach 3 in a position such asshown and described above with regard to FIG. 7C, for example. Typicallythe bougie 50, 50′ occupies a pathway extending naturally from theesophagus, through the stomach 3 and into the pylorus 3P, so as tooccupy a space similar to what is defined when a sleeve gastrectomy isperformed. The bougie acts as a guide so as to better standardize thesizes and locations of plications formed by the procedure as well as toprevent reducing the stomach 3 too aggressively, so as to ensure noblockage locations are inadvertently formed.

An attachment instrument 300″, a distal end portion of which is shown inthe isolated view of FIG. 11A, is inserted into the abdominal cavity andan end effector 300E″ formed on a distal end of the instrument 300″ andhaving an implantable device 10 releasably mounted thereto, is contactedto the stomach 3 in a manner as illustrated in FIG. 11B, such that theimplantable device 10 contacts the external wall of the stomach 3 and ispositioned between the stomach 3 and the end effector 300E″. In thisembodiment, instrument 300″ is provided with folding bars 330 that areelongated along the lengthwise direction of end effector 300E″ andpreferably extend substantially parallel to the longitudinal axis of theL-L of end effector 300E″. Folding bars are rotationally mounted toinstrument 300E″, each bar having a radially extending portion 330R thatis rotationally mounted to the instrument 300″ and from which the mainlongitudinal portion 330L extends, as shown in FIGS. 11A-11B. Thisarrangement allows the longitudinal portions 330L of the bars 330 to berotated relative to end effector 300E″ and implant 10 along arcs thatare at predetermined distances from the end effector 300E″. As shown inFIG. 11B and the cross-sectional view of FIG. 11C, the instrument 300″and implant 10 are inserted such that folding bars 330 slide under(posterior to) the stomach 3 and implant 10 and end effector 300E″ arecontacted to the stomach on top (anterior to) of the stomach. Once theinstrument 300″ and implant 10 are contacted to the stomach in themanner desired, with the end effector 300E″ and left folding baradjacent the bougie 50, 50′ as illustrated in FIG. 11C, the folding bars330 are rotated in opposite directions relative to one another to alevel about the same as the level of the end effector 300E″, such thatthey are side by side with the sides 300S″ of the end effector 300E″,see FIG. 11D, rather than below the end effector as they were in FIG.11C. Alternatively, one bar 330 can be rotated while the other bar 300remains stationary. The cross-sectional view of FIG. 11E betterillustrates the side by side positioning of the folding bars 330 and endeffector 300E″.

The surgeon next uses laparoscopic graspers 332 to manipulate tissue ofthe stomach 3 by grasping the stomach wall and plicating it into thespaces between the end effector 300E″ and the folding bars 330, asillustrated in the cross-sectional view of FIG. 11F. This plicatingprocedure allows the irregular shape of the stomach to be compensatedfor, where more plicating is provided at locations that extend furtherout from the bars 33 and relatively less plicating is performed inregions that extend out less far from the bars 330. For example, nearthe fundus 3F, where there is more stomach tissue, more tissue isplicated into the space 3SP then the amount that is plicated at thelower main body, nearer the antrum. The goal is to plicate as muchstomach tissue inside each gap 3SP as possible, so that the resultingplications formed will make the outside wall resulting tight. FIG. 11Gillustrates the stomach tissue having been plicated as desired.

At FIG. 11H the surgeon uses laparoscopic graspers 332 to grasp thestomach wall tissue and pull the outside wall 3 tight around the endeffector 300E″ as illustrated in FIG. 11H and the cross-sectionalillustration of FIG. 11I. A plurality of suction holes or ports 312 areformed in both end effectors 100E1, 100E2. Suction holes/ports 312 areoriented in a pair of rows extending along a length of end effector300E″, and are in fluid communication with a source of negative pressure(not shown) provided outside of the patient. For example, a suction linethat is in fluid communication with holes/ports 312 may extendproximally therefrom and be configured for connection to a source ofnegative pressure, such as the suction system of an operating room orother source of negative pressure. These suction holes/ports 312, uponapplication of suction therethrough and when tissue 3 is in contacttherewith, engaged the end effector 300E″ with the stomach tissue 3 andhold the stomach walls in the folded configurations shown in FIG.11H-11I, in a pair of plications ready to be finalized by fixing theirpositions.

Next, a conjunction member (e.g., mesh layer or other tissue ingrowthencouraging material) 460 is placed against the stomach tissue 3 incontact therewith, and spanning the plication line 3PL between theplications as illustrated in FIGS. 11J-11K. In this embodiment,conjunction member 460 is temporarily mounted in a paddle 460P. Paddle460P has a handle 460H extending proximally therefrom that a user canoperate from outside the patient to engage the paddle 460P with endeffector 300E″ in the manner shown, so as to contact the conjunctionmember 460 to the stomach 3 tissue as described above. The conjunctionmember 460 will become attached to the stomach 3, and the paddle 460Pwill release the conjunction member 460 before the paddle 460P isremoved.

At FIG. 11L piercing members/stitching needles 102′ are deployed fromthe end effector 300E″ to penetrate the double walls of the stomachplications and the conjunction member 460, see also, the detail view ofFIG. 11M. As noted above, the application of suction through suctionholes/ports 312 maintains the stomach 3 tissues engaged with the endeffector 300E″ as the piercing members/stitching needles 102′ penetratethe stomach tissues and conjunction member, as shown in thecross-sectional view of FIG. 11N.

In the embodiment shown, piercing members/stitching needles 102′ areconfigured with a slot 102S (see FIG. 11M) that opens to the distal endof 102′ but is closed at the proximal end of the slot 102S. Attachmentmembers/sutures 104 are attached distally to T-bars 108′ (although theT-bars could alternatively be replaced by umbrella-shaped members,grappling hooks, other hook-shaped members, or the like). T-bar 108′extends out of slot 102S when attachment member/suture 104 ispreinstalled through the hollow lumen in piercing member/stitchingneedle 102′. When piercing members/stitching needles 102′ are deployed,they carry the T-bars 108′ and therefore also attachment members/sutures104 along with them, as the T-bars stop out against the closed ends ofthe slots 102S. The portion of the T-bar that extends out of the slot102S is driven through the tissue 3 and conjunction member 460. When thepiercing members/stitching needles 102′ are withdrawn back out of theconjunction member 460 (FIG. 11O), the extending portions of the T-bars108′ catch in the mesh of the conjunction member 460 or other part ofthe conjunction member 460 and are passively deployed out of the needles102′ thereby anchoring themselves to the conjunction member 460 (seealso, the sectional view of FIG. 11Q). At FIG. 11P, the attachmentmembers/sutures are cinched using a suture tightening device of theinstrument 300″ and this pulls the T-bars 108′ tight against theconjunction member 460 as illustrated in FIGS. 11P-11Q.

Next, the bougie 50, 50′ is removed from the stomach 3 and the patient.The paddle 460P is detached from the conjunction member 460 and removedfrom the patient, the attachment portion of instrument 300E″ is removedfrom the patient, and attachment members/sutures 104 can be cinchedagain at this time, using the suture tightening device of instrument300E″ and the excess of the attachment member/sutures 104 resulting fromcinching are also trimmed, using the suture tightening portion ofinstrument 300″. The suture tightening portion is also removed, and theimplant 10 is inflated leaving the result shown in FIGS. 11R-11S.Inflation tubing 12 is then connected in fluid communication with aninflation port that allows changing the volume of the implant 10 fromoutside of the patient.

FIG. 11S is a cross-sectional illustration of the result of theprocedure described above, with implant 10 having been inflated. Thesleeve volume 3S can be adjusted by adjusting the volume of the implant10. The space 300SP left upon removal of the end effector 300E″ allowsfor room for the implant 10 to expand into upon further adjustment. Theends of the attachment members/sutures 104 opposite the ends fixed to108′ are pre-fixed to a layer of material 11, 11′, 11″, 11′ via suturelocks 110. Tab 11, 11′, 11″, 11′ encourages tissue ingrowth and is alsofixed to the expandable device 10, see FIG. 11S. For example, the tissueingrowth encouraging material may be a porous mesh of biocompatiblematerial such as DACRON® (polyester) or other fabrics that are known inthe art to encourage tissue ingrowth.

The folding bars 330 of this embodiment are shaped to nest tightly withthe bougie 50, 50′ (e.g., see FIG. 11Q). In at least one embodiment, thefolding bar adjacent the bougie 50, 50′ has a concave surface 330C tobetter conform to the bougie 50, 50′ for tighter nesting therewith, sothat the resulting plication can be as tight against the bougie 50, 50′as possible. The use of suction to hold the plications in position untilthey are more permanently attached with the attachment members 104′avoids potential injury and/or damage to the tissues that may resultwith alternative features such as needles or clamps.

FIG. 12A is a perspective view of an end effector 300E′ according toanother embodiment of the present invention. End effector 300E″′ can beused alternatively to end effector 300E, 300E′ or 300E″ in theinstruments described above. In this embodiment, piercingmembers/stitching needles 102″ are rotated about ninety degrees uponstorage in the end effector 300E′, relative to the storage positions ofthe previous embodiments. Thus, piercing members/stitching needles 102″are stored such that the sharp distal ends thereof point in a directionsubstantially parallel to the place of the contact surface 300C′ (orarranged more nearly parallel than perpendicular), rather thansubstantially perpendicular to it (or more nearly perpendicular thanparallel), as in the previous embodiments. This allows closerarrangement of piercing members/stitching needles, thereby providing atighter stitching pattern relative to the previous embodiments. Piercingmembers/“stitching needles 102” can be driven by a drive shaft which canapply more torque than the rack and pinion drive system used in theprevious embodiments. FIG. 12B schematically illustrates the stomach 3tissue being wrapped around the end effector 300E′, and this can beperformed according to any of the applicable techniques described above.

Next, at FIG. 12C, tissue pins/stabilizing pins 302 are deployed so asto temporarily hold the tissue in place during the stitching procedure.At FIG. 12D, piercing members/stitching needles 102″ are deployed 9B,from the surface of the end effector 300E″′ is begun, such as by use ofan actuator like 442 described in regard to FIG. 8A, although not shownhere. At FIG. 12D the piercing members/stitching needles 102″ are shownin an early stage of deployment of the process, e.g., after only one ortwo pulls of the actuator, or after otherwise driving the drive shaftfor only a short time. Note that the locations where the members/needles102″ pierce into the tissue 3 are substantially aligned with thelocations where the corresponding stabilizing pins/tissue pins 302pierce into the target. In the embodiment shown, the tip of the needle102 is aligned axially (i.e., at the same length along theproximal-distal axis of the stitching instrument, i.e., the left-rightdirection in FIG. 12D) with the tip of the stabilizing pin 302, whenboth are in their starting positions, ready to pierce into tissue 3.Also, pins 302 are angled in a direction opposite to a direction towardwhich the stitching needles 102 are angled, relative to the surface ofthe tissue 3, as they enter the tissue 3. In this way, the stabilizingpins/tissue pins 302 provide counter-traction and prevent the tissue 3from being dragged or bunched up or pushed away by the stitching needles102 as they sweep through the tissue 3, being rotated into and then outof the tissue.

At FIG. 12E, the piercing members/stitching needles 102″ have beendeployed into the anchors 108, followed by retraction of the piercingmembers/stitching needles 102″, leaving the anchor mates 106 mated withthe anchors 108 and the attachment members/sutures therefore alsoattached to the anchors 106 via anchor mates 108. The stabilizing/tissuepins 302 are then retracted, and the sutures are tightened, instrumentsare removed and the implant is inflated, as in any of the applicablemanners discussed above, leaving the final result schematicallyrepresented in FIG. 12F.

FIG. 12G shows an isolated perspective view of end effector 300E′without the stomach 3 being shown, for clarity of illustration of thetissue/stabilizer pins (shown deployed) and piercing members/stitchingneedles 102″ (shown partially deployed. FIG. 12H is an end view of theembodiment of FIG. 12G and FIG. 12I is a top view of the embodiment ofFIG. 12G.

FIG. 13A is a perspective view of an end effector 300E′ according toanother embodiment of the present invention. End effector 300E″′ can beused alternatively to end effector 300E, 300E′, 300E″ or 300E″′ in theinstruments described above. In this embodiment, piercingmembers/stitching needles 102″ are rotated about ninety degrees uponstorage in the end effector 300E′, like that described above with regardto end effector 300″. Additionally, this embodiment is provide with aplatform 300ER that is a separate component of the instrument thatslides into place as shown in FIG. 13D, and on which anchors 108 aretemporarily held.

FIG. 13A schematically illustrates the stomach 3 tissue having beenwrapped around the end effector 300E′, and this can be performedaccording to any of the applicable techniques described above.

Next, at FIG. 13B, tissue pins/stabilizing pins 302 are deployed so asto temporarily hold the tissue in place during the stitching procedure.At FIG. 13C, platform 300ER is slid to its operational position. In theoperational position, the operation surface of platform 300ER issubstantially normal to the remainder of the top surface of the endeffector 300E′, including the locations from which the piercingmembers/stitching needles 102″ are deployed, as can be seen in FIGS.13C-13D. At FIG. 13D, deployment of piercing members/stitching needles102″ from the surface of the end effector 300E″′ is begun, such as byuse of an actuator like 442 described in regard to FIG. 8A, although notshown here. At FIG. 13E, the piercing members/stitching needles 102″have been deployed into the anchors 108. Next, the piercingmembers/stitching needles 102″ are retracted, leaving the anchor mates106 mated with the anchors 108 and the attachment members/suturestherefore also attached to the anchors 106 via anchor mates 108. Theplate 300ER is withdrawn back to its non-operational/starting positionso that end effector 300E′ again appears as shown in FIG. 13A. Thestabilizing/tissue pins 302 are then retracted, and the sutures aretightened, instruments are removed and the implant 10 is inflated, as inany of the applicable manners discussed above, leaving the final resultschematically represented in FIGS. 13F-13G. FIG. 13F is a perspectiveschematic view and FIG. 13G is a schematic top view, showing theattachment members/sutures 104 along the plication line 3PL.

FIG. 14A is a perspective view of an end effector 300E′ according toanother embodiment of the present invention. End effector 300E″′ can beused alternatively to end effector 300E, 300E′, 300E″, 300E″′ or 300E′in the instruments described above. In this embodiment, two sets ofpiercing members/stitching needles 102″, are provided, and are rotatedabout ninety degrees upon storage in the end effector 300E′, like thoseof end effectors 300E″′ and 300E′. In this embodiment, one set ofpiercing members/stitching needles 102″ is deployed from a top (contact)surface of the end effector 300E′, while the second set of piercingmembers/stitching needles 102″ are deployed from the opposite side ofthe top (contact) surface of the end effector, see FIG. 14B. In thisway, stabilizer/tissue pins 302 are not needed because the forces of thetwo sets of piercing members/stitching needles 102″ on the tissuesoppose each other and drive the plications together, thereby maintainingthe plication as desired during the stitching process.

Alternatively to making a greater curvature plication, or an anteriorplication, a plication can be formed posteriorly, or one plication canbe formed on the anterior side and another plication can be formed onthe posterior side of the stomach 3. In an embodiment where a plicationis formed on the anterior surface and a plication is formed on theposterior surface, this can create a sufficient restriction of thestomach 3 to be effective for weight loss without the need to dissectthe blood vessels and connective tissues along the greater curvature 3Gof the stomach 3, which could reduce the risk of ischemia in the stomachtissues. At least the following embodiment is useful for thesealternative procedures. Alternatively, the following embodiment can beused in performing a greater curvature plication, where the bloodvessels and connective tissues (e.g., omentum 5) are dissected to allowfor a single, larger plication to be performed.

FIG. 15A illustrates an instrument 500 that includes suction for holdingstomach 3 tissue in place during a plication procedure. Air poppets 502are aligned inwardly of temporarily held anchors 108 with similarrelative positioning to the anchors and suction provided in theembodiment of FIGS. 8A-8N. In the embodiment of FIG. 15A however, airpoppets 502 can be used to individually capture stomach tissue during aplication procedure without losing suction from any of the other poppets502. When suction is applied to the poppets 502, the poppets 502normally remain closed and therefore do not lose any suction. As can beseen in FIGS. 15A, 15B and 15C, poppets 502 are raised above the maincontact surface 504 of instrument 500 and also above the level of theanchors 108.

Suction is applied through the back ports 506 of the instrument 500.Back ports 506 are in fluid communication with poppets 502 via conduits(not shown) that extend through the instrument 500. The poppets arespring loaded to the normal, closed position shown in FIGS. 15A-15C. Asstomach 3 wall tissue is pushed down on a poppet 502, this moves the toppart of the poppet downward, thereby opening its suction port. Thespring that biases the poppet 502 to the raised, off position is juststrong enough to overcome the force of the suction. Therefore whenadditional force is applied to it, such as the stomach tissue contactingthe top of the poppet 502, this compresses the spring and opens thesuction port of the poppet 502. FIG. 15C illustrates one of the poppettops having been removed to show the underlying spring 503 and suctionport 505. As stomach wall tissue 3 is pushed down on a poppet, likeshown in FIG. 15D, suction is applied to the stomach tissue therebyholding it in place. In the meantime, the other poppets 502 that havenot been contacted with tissue stay closed, keeping the suction levelconstant with no significant loss of suction in the system.

At FIG. 15E, another portion of stomach wall is pushed down against thenext poppet in sequence, thereby attaching that portion of the stomachwall 3. Again, the poppets 502 that have not been contacted remainclosed. Also, the previously attached stomach wall tissue remainsengaged by the previously contacted poppet 502. The process can berepeated in the same manner for all remaining poppet, at which time thestomach plications can be more permanently fixed in placed, such as bysuturing or the like.

When performing a stomach plication, a method for maintaining theexternal wall portions being joined in serosa to serosa contact isimportant as the healing of the serosa to itself is a means ofsupporting, strengthening and maintaining the plication in the desiredgeometry. FIGS. 16A-16D illustrate vacuum tubes 442 that can be employedas a mechanical means of ensuring that the stomach tissue is folded intoa desired configuration, and which may be used in embodiment such asthat shown in FIG. 8G or the like. Vacuum tube 442 can be connected to agauge such as a ball gauge or other type of gauge 443 outside of thepatient so that when all of the suction ports of the suction tube arecovered by stomach 3 tissue, the pressure in the gauge drops to asuction pressure indicative of such, but if the tissue breaks loose atone or more suction ports, the pressure level rises, indicating that theplication is not in proper position to be sutured. However, with onlyone vacuum tube 442 and gauge 443, it is possible that only one side ofthe plication may be covering the suction ports of the tube 442 thusleading to a false indication that the plication is ready to be suturedwhen, in reality, one side/fold of the stomach tissue is not properlypositioned, and therefore serosa to serosa contact would not result ifthe plication were to be sutured under these conditions. For example,FIG. 16A illustrates use of only one tube 442 and gauge 443. FIG. 16Bshows a possibility, using the arrangement of FIG. 16A, where the topleft side of the stomach 3TL covers the vacuum holes/ports 112 but it isnot in contact with the opposing fold 30F of the stomach 3. Likewise theright side fold at 3RS covers vacuum holes 112 but it is not in contactwith the tissue fold on the opposing side at 30S. 3I shows the idealpositioning of the stomach folds such that the opposing folds both coverthe ports 112 and are in the correct positions for being joined inserosa to serosa contact.

By providing two side-by-side vacuum tubes as illustrated in FIG. 16C,one vacuum tube 442 and its ports 112 can be dedicated to monitoring thepositioning of one fold of stomach tissue, and the adjacent vacuum tube442 and its ports can be dedicated to monitoring the positioning of theopposite fold of stomach tissue. To further ensure serosa to serosacontact of the opposing folds the vacuum tubes 442 can be provided to bemovable relative to on another. Accordingly, in a first, relativelyspaced apart position shown in FIG. 16C, the folds of stomach tissue canbe placed over the suction tube 442 and engaged thereby. Once the gauges443 register that the folds of tissue are properly covering the suctionholes/ports 112, the tubes 442 can then be brought closer together, asillustrated at FIG. 16D, all the while maintaining the tissue folds inengagement with the tubes 442 via the applied suction force and bringingthe tissue folds into serosa to serosa contact at the plication line3PL.

FIG. 17A is a perspective view of another embodiment of an attachmentinstrument 400″ according to the present invention, configured to beoperated from outside of a patient, with the end effector having beeninserted through a laparoscopic port or percutaneous opening and intocontact with the patient's stomach 3 (e.g., into the abdominal cavity ofthe patient), and to reduce the effective volume of the stomach 3 byperforming one or more plication procedures on it.

Attachment instrument 400″ includes a pair of offset, elongate endeffectors 400E″, one being positioned higher than other, butsubstantially parallel therewith in both length and pitch aspects, eachhaving a length greater than a width (typically at least more than twiceas great) formed at a distal end portion of instrument 400″. Endeffectors 400E1″, 400E2″ each include a distal end 400D, a proximal end400E and first and second sides 400S. An elongate shaft 420 extendsproximally from the proximal ends 400P of end effectors 400E1″, 400E2″.Shaft 420 has sufficient length so that a proximal end of the shaft 420extends out of the patient's body when the end effectors are placed onthe patient's stomach in a manner described below and illustrated inFIG. 17B.

A plurality of piercing members 102 (typically suture drivers such asstitching needles or the like) are positioned along a pair of rowsextending lengthwise along the end effectors 400E1″, 400E2″, see FIG.17B. Lower contact plates 4021, 4022 are spaced beneath and parallelwith an upper tissue contact surface 4041, 4042 of the end effectors400E1″, 400E2″, respectively, forming a gap 400G1, 400G2 therebetween asshown in FIG. 17B. A driving mechanism 410 is provided which isconfigured to drive folds of stomach tissue into the gaps 400G1, 400G2as shown in FIG. 17B. The driving mechanism can be the same as thatdescribed above with regard to the embodiment of FIGS. 8A-8B.

After preparing the patient, inserting a bougie 50, 50′ into the stomach3 in a manner as described above and forming either a percutaneousopening (e.g., puncture and opening leading from puncture into theabdominal cavity, for a percutaneous procedure) or a plurality of portsfor a laparoscopic procedure, end effectors 400E1″, 400E2″ of instrument400″ are inserted through the puncture or one of the ports and deliveredinto the abdominal cavity, where they are placed into contact with anexterior surface of the stomach 3. Typically, the end effectors aresubstantially aligned with the bougie 50, 50′ adjacent to the bougie 50,50′ on a location of the stomach nearer to the greater curvature 3G oron the greater curvature 3G with the bougie 50, 50′ being nearer thelesser curvature 3L. End effectors 400E1″, 400E2″ preferably contact thestomach 3 in an inferior to superior direction extending substantiallyover the body 3B and fundus 3F, but not over or in contact with thepylorus 3P, pyloric antrum 3PA, cardia 3C or gastroesophageal junction3GE.

Once the end effectors 400E1″, 400E2″ have been properly positioned asintended and contacted to the stomach 3, the roller bars 412 areoperated by operating the driving mechanisms to draw stomach tissue intothe gaps 400G1, 400G2 as illustrated in FIG. 17B. The plications oftissue formed are pulled over the lower roller bars 412 and under theupper roller bars 412. After the first stitch is completed, rollers 410gather stomach tissue until a desired amount has been driven through thegap 400G2, see FIG. 17B. The first stitch is formed along the first sideof the instrument, along end effector 400E1 and fixes the first fold oftissue, but then the rollers adjacent end effector 400E2″ can continueto be operated to increase the amount of stomach tissue rolled throughthe gap 400G2, see FIG. 17B-17C. The stitches are performed one at atime. A wedge can be pulled proximally with the instrument to push downone suture needle at a time as the wedge passes over them.

Once a satisfactory amount of stomach tissue has been drawn through gap400G2, the stitches are driven on the second side 400E2″ of instrument400″ to fix the other fold of tissue. A conjunction member 460 can beinstalled and sutures 104 cinched in the same manner as described abovewith regard to FIGS. 8P-8S. FIG. 17D shows instrument 400″ having beenremoved but sutures 104 not yet having been cinched. FIG. 17E shows theprocedure at the stage where the sutures 104 have been cinched, but notyet trimmed, and where the bougie 50, 50′ has been removed.

FIGS. 18A-18C illustrate use of a wrapping plication tool 600 used toleave a minimal amount of outer wall of the stomach 3 on the outside ofthe plication 3PL. The portion of the stomach wall 3W that was notcollected into the center of the plication determines the final geometryof the plicated stomach. The more wall that is collected into thecenter, the less there is on the outer perimeter and the more restrictedis the stomach lumen capacity internally. FIG. 18B illustrates how therolling action moves an outer wall surface location 604 into the centerof the plication, when location 606 is brought into apposition withlocation 602.

The method of FIGS. 18A-18C leaves a shorter stomach while also creatinga smaller lumen so that the overall pathway for food mimics that of agastric bypass. FIGS. 18D-18F show anterior view of a greater curvatureplication performed using wrapping plication tool 600. By joininglocation 608 with 610, the stomach is effectively shortened, and asmaller lumen 612 is formed in the stomach 3, so that the effects of agastric bypass are mimicked. FIG. 18G illustrate use of wrapping tool600 to move locations 614, 616, 618 to together to join the stomach 3tissue in two plications 3PL1, 3PL2.

FIG. 19A illustrates an instrument 700 used in performing a plication ofthe stomach 3 according to another embodiment of the present invention.In this embodiment, suction ports/holes 712 are spirally positionedalong roller body 702 as illustrated in FIG. 19A. FIG. 19B is anillustration of the stomach 3 with two lines or “rails” identifyinglocations of the stomach 3 intended to be joined in a plication 3PL.Instrument 700 is applied to rail location 3-1 with suction port 712-1engaging the stomach tissue there. Tube 702 can be rotated to open aspecific port, or to attach it to the stomach tissue. By selectivelyattaching and detaching ports, this separates the management of foldingthe stomach tissue and connecting the folds of tissue together.Instrument 700 is used to gather up the stomach tissue to be joined andthen the plication is manually stitched with conventional suture andneedle and laparoscopic tools.

FIG. 20A illustrates a method in which both of the opposing folds oftissue are passed in opposite directions between rollers 412, afterwhich they are connected at 3PL in serosa-to-serosa contact. FIG. 20Billustrates a method in which a first fold of stomach 3 tissue issecured such as by suturing. Subsequently, the stomach on the opposingside is rolled up further to gather more of the stomach 3 within theplication prior to fixing the opposing side at 3PL2.

In FIGS. 21A-21B a first line of anchors 750 is installed on the surfaceof the stomach, such as in a location generally following the greatercurve 3G and adjacent thereto, and a second line of anchors 760 isinstalled adjacent the lesser curve 3L and generally following thecurvature thereof. Then, an attachment member/suture 104 is laced aroundthe anchors 750, 760 and cinched down as shown in FIG. 21B. This drawsthe two sets of anchors 750, 760 up toward each other, thereby forming afold/plication in the stomach tissue and reducing the volume of thestomach 3, as shown in the cross-sectional illustration of FIG. 21C.

FIG. 22A illustrates an embodiment in which a mesh sheet 780 is attachedto the stomach 3 on a location where a plication is intended to beformed. Sheet 780 includes rails or other connectors 780A and 780B(e.g., male/female connectors or the like) on opposite sides thereof.Once sheet 780 is securely fixed to the stomach 3, the connectors 780Aand 780B are joined to one another, resulting in the plication 3PL shownin FIG. 22B. Mesh 780 is preferably formed of a material that encouragestissue ingrowth, such as any of the materials identified above as tissueingrowth encouraging materials. This then encourages tissue to grow intothe location 782.

FIG. 23A is a perspective view of a distal end portion of an instrument800 that is useful for folding the stomach in the performance of aplication procedure, to position the folded stomach tissues for manualstitching by a surgeon. Instrument 800 can be inserted through alaparoscopic port 802 when in a compact configuration in which foldingbars 830 are retracted to the compact configuration beneath the endeffector 800E as shown in FIG. 23B. FIG. 23C show a side view ofinstrument 800 in the compact configuration. Shaft 810 is a fixed shaftthat extends proximally of the end effector 800E and 812 is a rotationalshaft that extends proximally form end effector 800E and is linked tobars 830 so that an operator can rotate the shaft 812 from outside thepatient to rotate the bars 830 when they are in the abdominal cavity.

After establishing ports/pathway or other opening leading into theabdominal cavity from outside the patient, the omentum 5 and connectivetissues are dissected at the greater curve of the stomach to provideaccess thereto, the same as described above with regard to FIGS. 7A-7B.A bougie 50, 50′ may be inserted trans-esophageally and placed in thestomach 3 in a position such as shown and described above with regard toFIG. 7C, for example.

Once the end effector 800E and folding bars 830 have been insertedthrough the laparoscopic port 802 (or through a percutaneous opening fora percutaneous procedure or through a large opening if the procedure isan open surgical procedure) and have entered the abdominal cavity, theinstrument 800 is installed on the stomach such that the end effector800E is against one external wall of the stomach and the folding bars830 are in contact with the opposite external wall of the stomach,similar to what is shown in FIG. 11D with regard to instrument 300″.Folding bars 830 are elongated along the lengthwise direction of endeffector 800E and preferably extend substantially parallel to thelongitudinal axis L-L of end effector 800E. Folding bars 830 arerotationally mounted to instrument 800, each bar 830 having a radiallyextending portion 830R that is rotationally mounted to the instrument800 and from which the main longitudinal portion 830L extends, as shownin FIGS. 23A and 23C-23E. This arrangement allows the longitudinalportions 830L of the bars 830 to be rotated relative to end effector800E along arcs that are at predetermined distances from the endeffector 800E. Once the instrument 800 end effector 800E and foldingarms 830 are contacted to the stomach 3 and appropriately positioned inthe manner described above, the folding bars 830 are rotated in oppositedirections relative to one another, upwards to fold the stomach into a“U-shape”. The stomach 3 is not shown in FIGS. 23D-23E for clarity, toview the actions and components of the instrument 800.

Next, at FIG. 23E, tissue pins/stabilizing pins 302 are deployed fromend effector 800E into the folds of stomach tissue (not shown) totemporarily maintain the stomach folds in the desiredpositions/orientations for performing the plication. The surgeon mayassist in pushing or further pushing the stomach tissue folds down onthe pins 302 on both sides. This accurately positions the fold for avery tight, precise plication. Sutures are then manually placed by thesurgeon to attached the two folds of stomach in serosa-to-serosacontact, like illustrated in FIG. 12F, for example, after which the pins302 are retracted and the instrument 800 is removed. Optionallyinstrument 800 can be used along the greater curve 3G of the stomach toperform a plication after the omentum has been dissected. Optionally animplant may also be placed during the procedure in a manner also similarto that described in regard to FIG. 12F, as well as in other previousembodiments.

FIGS. 24A-24D illustrate another instrument 900 and use of instrument900 on the stomach 3 to created folds in the stomach 3 for performing aplication according to another embodiment of the present invention.Instrument 900 includes an elongated, channel-shaped base jaw 902 and amating jaw 904 that cooperates with base jaw 902. Base jaw 902 forms anopen channel at a distal end 902D thereof and has sides 902S that extendupwardly from base 902B to form the channel. Mating jaw 904 is hinged tobase jaw 902 at their proximal end portions as shown in FIGS. 24A and24C. In the end view of FIG. 24B, it is shown that when the jaws 902,904 are in a closed configuration, the mating jaw 904 is mounted suchthat the lower surface 904L is parallel to the upper surface 902U ofbase 902B and substantially parallel thereto, to form a gap 900Gtherebetween to provide a space for the stomach 3 so as to avoid overlycompressing the stomach tissue, thereby avoiding tissue damage,necrosis, etc. Additionally the base 902B may be provided with anopening 900H to further relieve stress on the stomach 3 tissue betweenthe jaws in the closed position, as a portion of the stomach 3 tissuetherebetween may be forced out through the opening 900H, therebyreducing the pressure on the tissues.

FIG. 24C illustrates the instrument 900 in an open position, in whichmating jaw 904 is pivoted away from base 902. Instrument 900 is theninstalled over the stomach 3 so that base 902 is on one side of thestomach 3 and mating jaw 904 is positioned on the opposite side of thestomach 3. After such placement, the upper jaw 904 and base 902 arebrought back together, to or at least toward the closed position,thereby forcing the stomach tissue 3 to conform into the channel, andshaping the stomach into a substantial “U-shape” as illustrated in FIG.24D. At this time, a surgeon can complete the plication by manuallysuturing the two folds of stomach tissue 3F1, 3F2 together, after whichthe instrument 900 can be at least partially opened to remove it off thestomach, and then closed again to make it as compact a possible forremoval from the abdominal cavity and patient. Optionally instrument 900can be used along the greater curve 3G of the stomach to perform aplication after the omentum has been dissected.

FIGS. 25A-25B illustrate instrument 1000 and use of instrument 1000 onthe stomach 3 to maintain the stomach in the desired folded conformationwhile sutures are being placed to hold the plication. After establishingports/pathway or other opening leading into the abdominal cavity fromoutside the patient, the omentum 5 and connective tissues are dissectedat the greater curve of the stomach to provide access thereto, the sameas described above with regard to FIGS. 7A-7B. A bougie 50, 50′ may beinserted trans-esophageally and placed in the stomach 3 in a positionsuch as shown and described above with regard to FIG. 7C, for example.

Instrument 1000 has a distal end effector 1000E and a handle 1000H thatextends proximally therefrom. Handle 1000H has a length sufficient sothat a proximal end portion of the handle can be grasped and operatedfrom outside the patient even when the end effector is in its operativeposition on the target stomach 3 tissue, such as illustrated in FIG.25B, for example. The end effector 1000E is curved about thelongitudinal axis L-L of the end effector 1000E such that the innerwalls of the end effector extend lengthwise, substantially parallel tothe longitudinal axis L-L. Thus end effector 1000E forms a partialcylinder, with a gap 1000G that extends the entire length of the endeffector 1000E so as to permit folded stomach tissue to enter in throughthe gap 100G and be held by the walls of the partial cylinder body ofthe end effector 1000E during the suturing of the plication. Endeffector 1000E may be made of a spring-like material, such as springsteel, Nitinol, or the like. After preparation of the surgical site asdescribed above, the stomach is folded over into the configurationintended to be maintained by the plication, so as to reduce theeffective volume of the stomach and thereby effect weight loss.Instrument 1000 is then inserted and end effector 1000E is slid over thefold of the stomach 3 tissue is then performed while end effector 100Eremains in place to ensure that the stomach 3 remains folded in themanner desired, so as to ensure serosa-to-serosa contact of the stomachtissues being sutured together. As noted above, the end effector 1000Ehas a gap 1000G that is sized to allow the outside wall of the stomach 3to remain in contact with one another, without being over compressed ordamaged. Once the suturing has been completed, the end effector 1000E isslid off of the folded stomach tissues and instrument 1000 is removedfrom the patient.

Alternatively instrument 1000 could be formed of wire. Furtheralternatively, instrument 1000 could be formed of two pieces of curvedmetal with a hinge and a spring to provided clamping action over thefolded stomach 3 tissues.

FIGS. 26A-26D illustrate a method of performing a plication of thestomach according to another embodiment of the present invention. Afterpreparing the surgical site, such as by the techniques described abovewith regard to FIGS. 7A-7C, for example, the greater curvature portionof the stomach 3G has been cleared of omentum and vasculature to theextent that it is ready to be folded in a manner desired, see FIG. 26A.The stomach is then folded, such as by using laparoscopic instruments(graspers or the like) and/or other instruments for a percutaneous oropen surgical procedure. Optionally, instrument 1000 may then be used tomaintain the stomach in the desired folded configuration with endeffector 1000E. Alternatively, the folded orientation can be maintainedusing graspers or other instruments.

At FIG. 26C a needle is used to advance an attachment member/suture 104through the edges of the fold at the plication line 3PL to fasten thefold in place. Attachment member 104 has an anchor mate 108 on a distalend portion thereof that interacts with the needle in the same manner asdescribed above with regard to piercing members/suture drivers 102, asthe needle also functions as a piercing member/suture driver 102. Also,anchor mate 108 mates with anchor 106 at the distal end of the plicationline 3PL as shown in FIG. 26C. The attachment member/suture 104 is thenpulled tight and tied at the proximal end of the stitch 104P.Optionally, bioglue (e.g., cyanoacrylate glue or other biocompatibleadhesive suitable for this purpose) may be applied to the stitch lineand plication line (fold seam) for added strength of the attachment.

FIGS. 27A-27B illustrate instrument 1100 and use of instrument 1100 onthe stomach 3 to form a plication by rolling according to an embodimentof the present invention. After establishing ports/pathway or otheropening leading into the abdominal cavity from outside the patient, theomentum 5 and connective tissues are dissected at the greater curve ofthe stomach to provide access thereto, the same as described above withregard to FIGS. 7A-7B. A bougie 50, 50′ may be insertedtrans-esophageally and placed in the stomach 3 in a position such asshown and described above with regard to FIG. 7C, for example.

Instrument 1100 has a distal end effector 1100E and a handle 1100H thatextends proximally therefrom. Handle 1100H has a length sufficient sothat a proximal end portion of the handle can be grasped and operatedfrom outside the patient even when the end effector 1100E is in itsoperative position on the target stomach 3 tissue, such as illustratedin FIG. 27A, for example.

After preparation as noted above, end effector 1100E is inserted intothe abdominal cavity and contacted to the stomach 3 as illustrate inFIG. 27A. Tissue pins/stabilizer pins 302 (not shown) are next deployedfrom the surface of end effector 1100E that contacts the stomach, so asto better mechanically engaged the stomach tissues. The operator thenrotates the handle 27B (counterclockwise in the embodiment shown in FIG.27B). This rotates the end effector 1100E which is temporarily attachedto the stomach tissue via pins 302, resulting in a rolling up of thestomach into a plication fold as illustrated in FIG. 27B. The instrumentis held in place as shown in FIG. 27B. The stomach can be held in therotated configuration by means of a clamp affixed to the shaftextra-corporally, while the plication line 3PL is fixed, such as bysuturing. Once the suturing has been securely performed, pins 302 areretracted back into the end effector 1100E, the end effector 1100E isrotated is the opposite direction and slid out from within the stomachtissues and instrument 1100 is removed from the abdominal cavity and thepatient. Alternative to pins 302, piercing members or needles such as102, 102′, 102″ could be deployed from end effector 1100E.

FIGS. 28A-28G illustrate instrument 50″ and use of instrument 50″ withinthe stomach to function as a bougie and optionally, to make a plicationin the stomach 3 by drawing on the stomach tissues from inside thestomach 3, although the attachment of the folds is preferably stillperformed by connecting the outside portions of the folds inserosa-to-serosa contact as described in previous embodiments.

Instrument 50″ comprises an elongate flexible tube 1210 having at leasttwo lumens therein. A first lumen 1212 is in fluid communication withsuction ports 1218, and is connectable, at a proximal end portionthereof, to a source of suction so as to apply suction to suction ports1218. A second lumen 1214 is in fluid communication with and inflatableanchor 1220 formed at a distal end portion of the instrument 50″. Aproximal end portion of the tubing forming lumen 1214 is connectable toa source of pressure, so as to fill the anchor 1220 with a pressurizedfluid to expand it to the configuration shown in FIG. 28A. Bydisconnecting lumen 1214 from the source of pressure (or discontinuingthe fluid communication with the pressurized fluid source such as by useof a valve and venting the portion of the lumen 1214 leading to theinflatable anchor 1220, the inflatable anchor can then be deflated tosubstantially the size of the tubing 1210 for easier installation orremoval from the patient. Optionally, a third lumen 1216 may be providedas a main lumen sized and configured to allow instruments such as, butnot limited to, an endoscope to be passed therethrough.

As noted above, a tube having known outside diameter can be used as acalibration tube for a plication procedure to adequately size theresidual lumen left in the stomach by the plication procedure.Accordingly, instrument 50″ can be used in any of the embodimentsdescribed herein that use bougie 50 or 50′, as an alternative to suchuse.

In this embodiment, instrument 50″ is useful not only as a bougie, butis operable as a tissue manipulator, utilizing suction through ports1218 to engage mucosal tissue and draw the entire stomach wall into afold, as described in more detail below.

At FIG. 28B instrument 50″ is placed transesophageally, down into thestomach 3, with the inflatable anchor 1220 placed towards the pylorus3P. At FIG. 28C the anchor 1220 is inflated by delivering pressurizedfluid thereto via lumen 1214. The anchor 1220 expands against the wallsof the pylorus 3P thereby anchoring the distal end of the instrument50″.

At FIG. 28D, the proximal end portion of instrument 50″ extending out ofthe patient is pushed on to deliver more of the tubing 1210 into thestomach. Because the tubing 1210 if flexible and the instrument isanchored at 1220, the tubing snakes around and into contact with themucosa of the greater curvature 3G of the stomach 3. Vacuum is appliedthrough suction holes 1218 via lumen 1212 and this attaches the tubing1210 to mucosa along the greater curvature as illustrated in FIG. 18Dand the cross-sectional view of FIG. 28E.

At FIG. 28F, the proximal portion of the tubing 1210 extending outsideof the patient is pulled on, to pull some of the tubing 1210 out of thestomach and thus shorten the length of the tubing 1210 that remainsinside the stomach. This causes the anchored tube to move toward thelesser curvature 3L (to the left in FIG. 28F) thereby pulling a fold 3Fof stomach tissue from the greater curvature 3G inward, as indicated inphantom in FIG. 28F and as shown more clearly in the cross-sectionalillustration of FIG. 28G. Thus, this procedure actively sizes the lumenthat will remain in the stomach after completion of the procedure, asthe fold 3F is actively pulled by the instrument 50″ into place againstthe bougie 50″ thereby accurately sizing the lumen all through thestomach 3. The plication shape is formed and the folds 3F1, 3F2 can befixated, joined by suturing, staples or other attachment features,including, but not limited to automated suturing as described herein,automated stapling, etc.

FIGS. 29A-29D illustrate instrument 50″′ and use of instrument 50″′within the stomach, according to another embodiment of the presentinvention, to function as a bougie and optionally, to make a plicationin the stomach 3 by drawing on the stomach tissues from inside thestomach 3, although the attachment of the folds is preferably stillperformed by connecting the outside portions of the folds inserosa-to-serosa contact as described in previous embodiments.

Instrument 50″′ comprises an elongate flexible tube 1310 and an endeffector 1300E formed in a distal end portion of tube 1310. FIG. 29Billustrates a plurality of members 112 interconnected by joints sorender the end effector 1300E flexible. Each member 112 includes atleast one suction port 1314 that opens through tubing 1310 forapplication of suction to the inner stomach wall (mucosa). The suctionports are in fluid communication with a lumen (not shown) in tubing 1310that is connectable to a source of suction proximal of instrument 5″′and outside of the patient. FIG. 29C shows a variation of the endeffector of FIG. 29C, in which members 1312′ are individually separableand snap together. Like the variation in FIG. 29B, the members 1312′ areformed to fit together to form ball and socket joints therebetween, andeach has at least one (multiple in the embodiments shown) suction port1314 that opens to the outside of the instrument 50″′. FIG. 29Dillustrates the flexibility provided by the members 1312, 1312′ in theend effector 1300E. The portion of the tubing 1310 proximal of endeffector 1300E is flexible but somewhat stiff, similar to theconsistency of a garden hose, such that it can be pushed withoutbuckling, but it is still flexible enough to curve to conform totortuosity of the pathway that it is inserted through, such as curvatureof the esophagus, stomach, etc., while still being capable of beingadvanced by pushing on it from a proximal location outside the mouth ofthe patient.

Although instrument 50″ is flexible in bending, as illustrated in FIG.29D, it is rigid when axially torqued about its longitudinal axis.

In this embodiment, instrument 50″′ is useful not only as a bougie, butis operable as a tissue manipulator, utilizing suction through ports1314 to engage mucosal tissue and torque the entire stomach wall to rollit into a fold, as described in more detail below.

After connecting instrument 50″′ to a vacuum source, instrument 50″′ isinserted into the patient's esophagus until it enters the stomach 3. Thedistal tip 1300D of instrument 50″′ is blunt and finds its way towardthe pylorus 3P. The end effector 1300E is flexible, as noted, and so asmore of the instrument if fed into the stomach after contacting the tip1300D in the pylorus 3P, the end effector 1300E curves into contact withthe greater curvature of the stomach 3 inside the stomach, much likeinstrument 50″ does in FIG. 28D. The vacuum source is turned on and themucosa of the greater curvature 3G is thereby attached to the suctionports 1314. A proximal portion of instrument 50″′ that extends out ofthe patient is than axially torqued. Since the instrument 50″′ is rigidunder axial torqueing, this rotates the end effector 1300E, therebyrolling up the stomach to a folded configuration suitable for plication.When multiple suction ports 1314 are provide in each member 1312, 1312′,this is advantageous as the members attach to multiple locations of themucosa upon rotating and thereby more securely hold the plication duringsuturing. The plication line can be sutures via conventionallaparoscopic techniques. Once the plication line has been securelysutured, the vacuum can be turned off and instrument 50″′ can bewithdrawn from the stomach 3 and the patient. Alternatively, each member1312, 1312′ could be provided with a large suction slot rather than aplurality of suction ports. Instrument 50″′ can be used alternatively tothe use of 50, 50′ or 50″ in any of the other embodiments describedherein that refer to use of bougie 50 or 50′. Alternatively, thestiffness of 50, 50′ or 50′″ can be adjustable by means of a taperedmandrel inserted into an axial lumen. Since the thinner portions of themandrel are lower in stiffness than the proximal portions, the mandrelcan be advance or retracted inside the lumen to adjust the stiffness tothe appropriate level for apposition to the greater curvature of thestomach.

FIGS. 30A-30D are plan, end, top and perspective view of an instrument1400 useable to create a suture line for joining stomach tissuestogether in a plication. Instrument 1400 includes first and second basemembers 1400A and 1400B each having a contact surface configured tocontact stomach 3 tissues to be attached, and to sandwich those tissuestherebetween. The contact surfaces each have a plurality of alternatingdepressions 1400D and 1400P that are configured to mate with thedepressions 1400D and protrusions 1400P of the other base member whenthe base members are brought together. Accordingly, the sequence ofdepressions and protrusions of one base 1400A are offset from that ofthe other base 1400B as shown in FIGS. 30A and 30B, so that the opposingprotrusions 1400P mate with depressions 1400D and the opposingdepressions 1400D mate with protrusions. When these bases 1400A, 1400Bare separated, the stomach tissues to be sutured are placed between thebases at 1402. When the bases are pressed together, the matingprotrusions 1400P and depressions 1400D deform the stomach 3 tissuesaccordingly, forming an undulating shape in the tissues. Once the bases1400A, 1400B are fitted together (FIG. 38C, 38D) with the stomachtissues therebetween, a wire 1404 is inserted into a predefined pathwaybetween the bases 1400A, 1400B. This wire passes through both layers ofstomach tissue 3 that are to be joined, entering and exiting the manyundulations of the tissue pair. An attachment member/suture 104 is fixedto the proximal end of the wire 1404. Once the distal end of the wire1404 emerges from between the bases 1400A, 1400B at the opposite endfrom which it was inserted, it can be pulled out from between the bases,1400A, 1400B, thereby dragging the suture through the same pathway thatthe wire had taken thorough the undulations of the tissue layers. Thesuture 104 can then be secured to the stomach 3 tissue near bothproximal and distal ends of the bases 1400A, 1400B. Then the bases1400A, 1400B can be separated and removed, leaving the tissues sewntogether by suture 104.

FIG. 31A is a plan view of an instrument 1500 that can be used tomanipulate stomach tissue in furtherance of a plication procedureaccording to an embodiment of the present invention. Instrument 1500includes an elongate shaft 1502 and a handle 1504 formed at a proximalend portion thereof. At least one suction hole (preferably a pluralityof suction holes 1512, as shown) is formed in the end effector 1500Eformed at the distal end portion of the shaft 1502, see FIG. 31B. Asource of suction can be connected to instrument 1500 at port 1506 inhandle 1504. Port 1504 is in fluid communication with holes/ports 1512via shaft 1502. The distal end of the shaft is closed. Upon placement ofend effector 1500E in contact with stomach 3 tissue and actuation ofvacuum applied to suction holes 1512, the suction holes, in contact withthe stomach 3 tissue, engage the stomach tissue with sufficient forcesuch that movement of the instrument 1500, such as by an operator movingthe handle 1504 from outside the patient to effect movement of the endeffector 1500E, in turn moves the stomach 3 tissue. The suction openings1512 can be designed so that a collection of instruments 1500 havingdifferent sizes and/or numbers of openings 1512 can be provided to allowfor the appropriate length of tissue to be grasped. Alternatively,instrument 1500 may be provided with the ability to close off one ormore openings. A relatively smaller opening or single opening 1512 couldbe used to attached to tissue at a single point location, whereas longeror multiple openings 1512 can be used to manipulate longer lengths oftissue 3. For suturing tissues together, two or more instruments 1500may be used to manipulate the tissues to be joined to move them into thedesired locations for suturing. For plication, different parts of thestomach 3 can be grasped using vacuum, lifted, and then placed closetogether.

FIGS. 32A-32C illustrates variations of an instrument 1600, 1600′ thatcan be used in the performance of a plication procedure on the stomach,according to an embodiment of the present invention. Instrument 1600 isrigid and formed as a T-shaped spine, having a deformation spine 1602and a cross member 1604. Instrument 1600 can be made of biocompatiblemetal or rigid plastic. In use, instrument 1600 is pressed against thestomach so as to trap and plicate the stomach 3 tissue as shown. Thedeformation spine 1602 causes folding of the stomach tissue and thecross member maintains the outer folds of the plication evenly and upagainst the deformation spine in preparation for joining them together,such as by suturing or the like. The deformation spine 1602 may beprovided with a slot 1602S (see FIG. 32C) or other opening or openingsthat allow suturing therethrough, but still permits the instrument 1600to be removed after suturing has been performed. In the variation ofFIG. 32C, side guides 1606 extend from the edges of cross member 1604 insubstantially the same direction that deformation spine 1602 extends in,thereby better channeling the tissue folds between the deformation spineand the respective side guides 1606. Once the folds of the stomach havebeen connected together, instrument 1600 can be slid out and removedfrom the patient.

Further alternatively deformation spine 1602 may contain a mechanismthat automatically holds and/or seals the plicated stomach together.

FIG. 33 illustrates an embodiment that employs an instrument 1600together with a forked clip 1650. The empty, relaxed stomach 3 is drapedover the instrument 1600 and deformation spine 1602 deforms the stomach3 tissues, creating the plication. The forked clip 1650 is then appliedover the folded stomach 3 tissues to hold them in place against thedeformation spine 1602 of instrument 1600. Instrument 1600 is thenremoved, sliding the deformation spine 1602 out from between the foldedtissues and leaving the folds of the stomach clipped together byinstrument 1650, thereby reducing the volume of the stomach.Additionally the clamped, folded tissues can be sutured, stapled orotherwise further connected, and instrument 1650 can be left in place orremoved.

FIG. 34 illustrates a dumbbell-shaped implant 10 that can be implantedin a plication according to procedures described herein. Implant 10includes an elongate, substantially cylindrical, central body portion10B having a first cross-sectional dimension (diameter) with enlargedportions 10E formed at both ends of the central body portion 10B. Thenenlarged portions are bulbous and have a cross-sectional dimensionlarger than the cross-sectional dimension of the central body. In theembodiment shown, each enlarged portion is substantially spherical andhas a cross-sectional dimension (diameter) 10C2 that is greater than thecross-sectional diameter 10C1 of the central body 10B.

A plicated stomach can expand over time. By attaching an inflatableimplant 10 in the folded stomach 3 as illustrated in FIG. 34, thisallows adjustment of the compression on the stomach, and thuscompensation for expansion of the stomach, by expanding the implant 10further, without the need for further surgery. The main body (narrowsection) of the implant 10 is attached inside the plicated stomach,while the enlarged portions 10E extend out towards the fundus end of thestomach 3 as well as the antrum. The implant is inflatable via asubcutaneous port 80 in fluid communication with an inflation tube 12which we have already described in detail previously. By making theimplant 10 dumbbell-shaped, the size can be made universal. In patientswith a relatively shorter length of the plicated stomach 3, the enlargedends 10E of the dumbbell-shaped implant 10 will occupy space and preventthe motion of the implant 10 out of its intended location. In plicatedstomachs 3 that are relatively long, the dumbbell-shaped implant 10 willstill function by providing adequate restriction while one or both ofthe enlarged portions are inflated inside of the plicated area. Thedumbbell shape of the implant 10 can reduce the number of attachmentsrequired since additional anchoring is provided by the enlarged ends10E. This can result in smaller instruments being used to perform theattachment procedures and enable linearity of the attachment locations,thus overcoming challenges in stitching along the curvature of thestomach. Alternative shapes for implant 10 include, but are not limitedto: substantially cylindrical (already described above), disc-shaped orcube-shaped.

FIGS. 35A-35C are perspective views of an attachment instrument 400″′according to another embodiment of the present invention, configured tobe operated from outside of a patient, with the end effector having beeninserted through a laparoscopic port or percutaneous opening and intocontact with the patient's stomach 3 (e.g., into the abdominal cavity ofthe patient), and to reduce the effective volume of the stomach 3 byperforming one or more plication procedures on it. Of course instrument400″′ could also be used during open surgery.

Attachment instrument 400″′ includes an elongate end effector 400E″′comprising first and second end effector portions 400E1″′ and 400E2″′and operates similarly to attachment instrument 400 with notabledifferences described hereafter. A joint 423 is provided intermediate ofshaft 420″′ that permits the operator, after inserting the end effector400E″′ into the abdominal cavity to operate the handle 430″′ fromoutside of the patient to articulate the end effector 400″′ and distalend portion 420D of shaft 420″′ relative to the proximal end portion420P of shaft 420″′ and handle 430″′. This can assist in orienting theend effector 400E″′ more tangentially to the stomach 3 before contactingit, than what otherwise might be possible in embodiments where the endeffector has to remain aligned with the entire shaft and handle, theangle of which is sometimes not optimum in view of the angle of approachneeded to be taken when inserting the instrument from outside thepatient and into the abdominal cavity. An example of this is illustratedin FIG. 3I.

FIG. 35A illustrates instrument 400″′ in a configuration where lowercontact plate 402″′ on end effector portion 400E2″′ is spaced beneathand parallel with an upper tissue contact surface 404″′ on the endeffector portion 400E1″′ of the end effector 400E″′, forming a gap 400Gbetween plate 402″′ and surface 404″′ as shown. Actuators 432D and 432Pare cyclically actuatable to operate distal ratchet driving mechanism434D and proximal ratchet driving mechanism 434P respectively, to varythe distances between the plate 402″′ and surface 404″′ at 434D and 434Pand locations therebetween. The independently operable ratchet systems434D, 434P are independently controllable to better account for variedthicknesses of the stomach 3 along the plication line.

Optionally the end effector 400E″′ may be slightly curved relative toits longitudinal axis, as shown, to better match the curvature of thebougie 50, 50′, 50″, 50″″ and/or lesser curvature 3L of the stomach 3,so as to achieve a plication line 3PL that better conforms to the lessercurvature 3L resulting in a more consistent cross-sectional size andshape of the lumen that is left in the reduced stomach, see FIGS. 35Dand 35E. Alternatively, the end effectors 400E″′ could be designed tohave linkages along their length to allow the user to adjust the overallcurvature to match the curvature of the bougie 50, 50′, 50″, 50″′ andinner curvature of the stomach 3 (i.e., lesser curvature 3L).

Actuator/button 436 when pressed/actuated, activates a suction systemsupplied with suction via suction line 116 and which functions likepreviously described suction ports used to help ensure that tissue to beplicated is properly positioned. Actuator/button 438 has an appearancelike actuator/button 436 but is positioned on the opposite side ofhandle 430″′. When pressed/actuated, actuator/button 438 activates thetissue clamping system of instrument 430″′, which actuates smallclamping features along the end effectors 400E″′ that clamp onto thestomach tissue at locations near the locations where the tissue contactsthe suction features. This tissue clamping thereby complements theengagement of the tissue by the suction system. Upon properlypositioning the stomach tissue 3 between the surfaces 404″′ and 402″′,the drivers 434P, 434D are driven as necessary to contact the tissuesall along the plication line and adjust the gap 400G so that thesurfaces will apply pressure evenly along the plication line duringclamping. Upon actuating the clamping system using actuator 438, thecontact surfaces 402″′, 404″′ clamp the tissues to be attached, asillustrated in FIG. 35B. Further adjustment of the ratchet drivers 434P,434D may be performed at this time to achieve a more even distributionof clamping force, if needed. FIG. 35C illustrates the ability of thedrivers 434P, 434D to completely close the end effector 400E″′ so thatthere is no gap 400G between 402″′ and 404″′. FIG. 35F is an enlarged,detail view of the portion of FIG. 35A outlined by box 35F. FIG. 35Fbetter shows the suture anchors 106 and suction ports 112 in endeffector 400E2″′ that are open to surface 402″′.

FIG. 36A is a side view of an attachment instrument 600 according toanother embodiment of the present invention. Instrument 600 isconfigured to engage stomach tissue via suction (and optionally,additional mechanical clamping force as described after this embodiment)like instruments 100, 200, 400, 400′, 400″, 400″′, etc., but unlikeinstrument 100, 400, 400′, 400″ and 400′″, instrument 600 is notconfigured to perform suturing/fixation of the serosal tissues together(other than temporarily by clamping action until something morepermanent is installed). In this embodiment, instrument 600 is used toengage the stomach tissues by suction or by suction and mechanicalclamping.

Instrument 600 can be inserted into the abdominal cavity and a workingend thereof is positioned over a location on the stomach 3 where aplication line 3PL is intended to be formed. The working end is thedistal end portion of the instrument 600 and includes a first endeffector 600E1 and a second end effector 600E2 extending alongside andopposing first end effector 600E1. These end effector 600E (600E1,600E2) can be straight, or can be slightly curved relative to itslongitudinal axis, as shown in FIG. 36A, to better match the curvatureof the bougie 50, 50′, 50″, 50″″ and/or lesser curvature 3L of thestomach 3, so as to achieve a plication line 3PL that better conforms tothe lesser curvature 3L resulting in a more consistent cross-sectionalsize and shape of the lumen that is left in the reduced stomach.Alternatively, the end effectors 600E could be designed to have linkagesalong their length to allow the user to adjust the overall curvature tomatch the curvature of the bougie 50, 50′, 50″, 50″′ and inner curvatureof the stomach 3 (i.e., lesser curvature 3L).

One of end effectors 600E1, 600E2 can be placed on a posterior surfaceof the stomach 3 and the other can be placed on an anterior surface ofthe stomach 3 along a line opposed to a line of the posterior surfacethat the first end effector contacts, like that described above withregard to instrument 200 in FIG. 5D. The end effectors 600E1, 600E2engage the surfaces of the stomach 3 that they are contacted to byapplication of negative pressure through suction ports 112 (see FIG.36B) defined in the contact surfaces 602, 604 of the end effectors600E2, 600E1 (and optionally, additional mechanical clamping force asdescribed in more detail below), respectively. The engagement forces aresufficiently strong so that when the end effectors 600E1, 600E2 areseparated (moved away from one another) as the portions of the stomachwall engaged by the end effectors are also drawn apart, therebyexpanding the interior volume within the stomach 3 (like shown in FIG.5E when using instrument 200).

Next, a portion of the stomach forming at least a portion of the greatercurvature 3G is plicated (i.e., tucked) into the gap 600G formed byseparating the end effectors 600E1, 600E2 (like shown in FIG. 5F whenusing instrument 200). The plicated portion of the stomach 3 is foldedto an extent that it is located on the opposite side of the intendedplication line, relative to its pre-plicated location, as can beobserved by comparing FIG. 5E with FIG. 5F. Optionally, but preferably,prior to plicating the portion of the stomach 3, the operator of theinstrument 600 may rotate the instrument 600 by about ninety degrees(counterclockwise in the embodiment shown in optional step of FIG. 5F′)about its longitudinal axis. This option positions the stomach 3 toallow gravity to assist in plicating the portion 3G through the gap600G, making the plicating much easier as the portion 3G “falls” inthrough gap 600G.

Once the portion 3G has been folded appropriately according to eitheroptional technique described above, the instrument 600 is then operatedto move the end effectors 600E1, 600E2 together again thereby closingthe plication (like shown in FIG. 5G when using instrument 200). At thistime, a surgeon sutures the plication so as to more permanently attachedthe stomach tissues together in serosal to serosal contact so as tomaintain the configuration shown in FIG. 5G. Thus, rather than using aninstrument to perform the suturing via an automated instrument like inFIGS. 5G-5L, instrument 600 is configured for manual suturing of theplication. The surgeon will typically manually sew, via needle 602 andsuture 104 (FIG. 36C) a set of interrupted sutures 604 along theplication line, followed by a second suture line 606 (see FIGS.36D-36E), which may be a continuous running stitch or a second set ofinterrupted sutures. Further alternatively, only one row of sutures 604,typically a set of interrupted sutures, may be employed, as illustratedin FIGS. 36F-36G.

As a further option, an expandable implant 10 may be implanted (manuallysutured in place by a surgeon, like descried above with regard to FIG.5L except using instrument 600 and replacing instrument 150 by manualsuturing) to fill the inside of the plication 3PL. The implant 10 may bea silicone bladder, for example, capable of being inflated bybiocompatible fluid such as liquid, gas, or a combination of fluids(gases, liquids, or liquids and gases). Implant 10 is connected via filltubing 12 in fluid communication with a subcutaneous fill port 80, sothat the fill volume of implant 10 can be adjusted after implanting itas described from a location outside of the abdominal cavity (e.g., byan operator accessing the subcutaneous fill port 80 with a needle aloneor a needle attached to a pressurized source of fluid). Other implants10 may be substituted, but need to be expandable and are preferablycontrollable as to amount of expansion. A tab or wing 11, 11′, 11″, 11″′may be provided to extend from the expandable body of the implant 10 andcan be inserted between the tissue folds at the plication suture line sothat the attachment members/sutures 104 are also installed through thetab or wing 11, 11′, 11″, 11″′ to thereby securely hold the implant inplace, as illustrated in FIG. 5L. The tab or wing 11, 11′, 11″, 11″′ maybe made of a mesh-reinforced silicone, for example. Alternatively, theimplant 10 may be fixed in place by connecting only to the superior andinferior ends of the plication suture line, or by connecting to one ormore of the interrupted sutures.

Instrument 600 includes an elongate end effector 600E comprising firstand second end effector portions 600E1 and 600E2 and operates similarlyto attachment instrument 400″′ with regard to tissue attachment,separation and clamping functions. As already noted however, instrument600, unlike instrument 400″′ does not perform suturing of the plication.A joint 623 is provided intermediate of shaft 620 that permits theoperator, after inserting the end effector 600E into the abdominalcavity to operate the handle 630 from outside of the patient toarticulate the end effector 600E and distal end portion 620D of shaft620 relative to the proximal end portion 620P of shaft 620 and handle630. This can assist in orienting the end effector 600E moretangentially to the stomach 3 before contacting it, than what otherwisemight be possible in embodiments where the end effector has to remainaligned with the entire shaft and handle, the angle of which issometimes not optimum in view of the angle of approach needed to betaken when inserting the instrument from outside the patient and intothe abdominal cavity.

In certain embodiments, joint 623 is controlled at handle 630 through arod linked to a threaded traveller riding on a threaded screw. Turningthe threaded traveler such that it rides distally along the long axis ofthe device in turn pushes the rod. The rod extends joint 623 such thatdistal end portion 620D forms a more obtuse angle with respect toproximal end portion 620P. Conversely, turning the threaded travelersuch that it rides proximally along the long axis of the device retractsjoint 623 such that distal end portion 620D forms a more acute anglewith respect to proximal end portion 620P. It is understood that othermechanical systems for extending and retracting joint 623 arecontemplated as within the scope of the invention.

FIG. 36A illustrates instrument 600 in a configuration where lowercontact plate 602 on end effector portion 600E2 is spaced beneath andparallel with an upper tissue contact surface 604 on the end effectorportion 600E1 of the end effector 600E, forming a gap 600G between plate602 and surface 604 as shown. Actuators 632D and 632P are cyclicallyactuatable to operate distal ratchet driving mechanism 634D and proximalratchet driving mechanism 634P respectively, to vary the distancesbetween the plate 602 and surface 604 at 634D and 634P and locationstherebetween. The independently operable ratchet systems 634D, 634P areindependently controllable to better account for varied thicknesses ofthe stomach 3 along the plication line.

Actuator/button 636 when pressed/actuated, activates a suction systemsupplied with suction via suction line 116 and which functions likepreviously described suction ports used to help ensure that tissue to beplicated is properly positioned. Actuator/button 638 has an appearancelike actuator/button 636 but is positioned on the opposite side ofhandle 630. When pressed/actuated, actuator/button 638 activates thetissue clamping system of instrument 630, which actuates small clampingfeatures along the end effectors 600E that clamp onto the stomach tissueat locations near the locations where the tissue contacts the suctionfeatures. This tissue clamping feature is described in greater detailbelow. This tissue clamping thereby complements the engagement of thetissue by the suction system. Upon properly positioning the stomachtissue 3 between the surfaces 604 and 602, the drivers 634P, 634D aredriven as necessary to contact the tissues all along the plication lineand adjust the gap 600G so that the surfaces will apply pressure evenlyalong the plication line during clamping. Upon actuating the clampingsystem using actuator 638, the contact surfaces 602, 604 clamp thetissues to be attached, similarly to what is shown in FIG. 35B withregard to instrument 400″′. Further adjustment of the ratchet drivers634P, 634D may be performed at this time to achieve a more evendistribution of clamping force, if needed. The drivers can be configuredwith the ability to completely close the end effector 600E, if desired,so that there is no gap 600G between 602 and 604. FIG. 36B is anenlarged, detail view of the portion of FIG. 36A outlined by box 36B.FIG. 36B better shows the suction ports 112 in end effector 600E2″′ thatare open to surface 602. Additionally, FIG. 36B better shows therecesses or scallops 610 formed in the end effectors 600E1 and 600E2 allthe way through the thicknesses thereof, including the contact surfaces604 and 602. The recesses/scallops 610 in end effector 600E1 are alignedwith the recesses/scallops 610 in end effector 600E2 and are configuredand dimensioned to facilitate manually installing/sewing sutures 104therethrough by the surgeon. By installing interrupted sutures through aplurality of the recesses/scallops 610 (typically all recesses/scallopsthat sandwich stomach tissue are sutured, although fewer could besutured) this fixes the plication line 3PL independently of theinstrument 600, so that the stomach tissue are held in serosa-to-serosaapproximation after completion of the suturing, and unclamping andremoval of the instrument 100. The interrupted sutures do not constrainthe end effectors 600E1, 600E2 in any way, so that the end effectors600E1, 600E2 can be maintained clamping the tissues until at least thefirst line of interrupted sutures have been completed. Removal of theend effectors and instrument 600 can be readily accomplished withoutaffecting tensioning of the sutures or the condition of the plicationline.

FIGS. 37A-37C are schematic representations illustrating functioning ofa tissue engagement arrangement for engaging stomach tissue duringprocedures discussed above. Alternative to the use of suction only, thisapproach uses secondary mechanical clamping, in addition to suction toengage the stomach tissues. In the schematics shown, the surface of thepage represents contact surface 404″′. The distal end of the instrumentis to the left in the schematics and the proximal direction is to theright. With the secondary mechanical clamping non-actuated as shown inFIG. 37A, stomach tissue is pulled into the slots 112 by application ofsuction through the slots 112. Secondary clamp actuator 138, which isoperable by the user of the instrument from outside of the patient, forexample, by actuating actuator/button 438, is in its non-actuatedposition as shown in FIG. 37A.

By drawing the actuator 138 proximally relative to the remainder of theinstrument, actuator lobes 138L of actuator 138 drive clamping wires 139against the stomach tissues engaged by the slots 112 and wedge thetissues against the inside surface of the slots 112. To release thesecondary clamping, the operator can pull the actuator 138 furtherproximally so that the lobes 138L are positioned in between the slots112 as illustrated in FIG. 37C, allowing clamping wires 139 toresiliently return to positions away from the tissues so that they nolonger clamp the tissues. Alternatively, the operator can push theactuator 138 back distally, allowing the camping wires to resilientlyreturn to positions away from the tissues so that they no longer clampthe tissue in the slots 112.

FIGS. 38A-38H provide various partial views of an instrument 100′ thatemploys suction as a primary clamping feature and a mechanical secondaryclamping feature according to an embodiment of the present invention. Itis noted here that although the instrument 100′ is similar to theconstruction and function of instrument 100 shown in FIG. 3A, that thesecondary mechanical clamping features shown and described in thisembodiment are not limited to instruments 100 and 100′, but can beemployed in any of the instruments described herein that use suction toengage the stomach tissue, as additional securement of the stomach.These features are also not limited to those instruments that bothengage the stomach tissue and attach the tissues in serosa-to-serosacontact, as they can also be employed in instrument that engage bysuction, but do not perform suturing (such as instruments 200 and 600,for example). It is further noted that although the embodiment 100′ inFIG. 38A provides a series of individual actuators 122′ for individuallydriving piercing members/suture drivers 102 into suture anchors 106,that typically instruments described herein use a sled pulled along by acable to automatically press the piercing members/suture drivers 102through the stomach tissues and into the suture anchors 106, asdescribed above. The piercing members/suture drivers 102 can bepressed/driven into the tissues all at once simultaneously, in any ofthe manners described previously and below. Alternatively, the piercingmembers/suture drivers 102 may be driven individually, as noted above.FIGS. 41A-41E are various partial views illustrating an alternativedriving arrangement for an attachment instrument, which is alternativelyavailable for instrument 100′ but can also be readily adapted for use inother attachment instruments described herein. An actuation mechanism1020 is provided for individually driving piercing members/suturedrivers 102 into suture anchors 106. Actuation mechanism 1020 includes asled 1022 that pulled along by a cable (or, alternatively, pulled orpushed by a screw drive mechanism or other driving mechanism) to pressthe piercing members/suture drivers 102 through the stomach tissues andinto the suture anchors 106, as described above. A driver head 1024 ismounted on top of each piercing member/suture driver 102 as shown. Asillustrated in the enlarged partial view of FIG. 41B, a leading ramp orcam 1026 mounted on a proximal end portion (but could be on the distalend portion for embodiments wherein the sled is pushed rather thanpulled) of sled 1022 and is provided with a cam surface 1028 configuredto cooperate with cam surface 1030 of driver head 1024 to drive thepiercing member/suture driver 102 further out of the instrument as shownby the second to the leftmost piercing member/suture driver 102 in FIG.41A. As the sled 1022 advances further and the leading ramp 1030 clearsthe drive head 1024 that it has just depressed, a trailing ramp or camsurface 1032 of a trailing ramp 1034 that is mounted on a distal endportion (but could be on the proximal end portion for embodimentswherein the sled is pushed rather than pulled) of sled 1022 cooperateswith cam surface 1036 of driver head 1024 to drive the piercingmember/suture driver 102 in the opposite direction, further into theinstrument, back to its undeployed, starting position as shown by theleftmost piercing member/suture driver 102 in FIG. 41A. At the sametime, the leading ramp 1030 engages the next driver head to deploy thenext piercing member/suture driver 102. This process continues tosequentially and individually deploy each piercing member/suture driver102 until all of them have been deployed. Flexure arms 1038 with stops1040 are provided both proximally and distally of each piercingmember/suture driver 102 to guide the placement and travel of eachpiercing member/suture driver 102 and to provide an end stop to thereturn travel as the piercing member/suture driver 102 returns to itsundeployed position. A pull cable 1042 is illustrated in FIG. 41B topull the sled 1022 proximally relative to the end effector.Alternatively, a pulley could be employed so that when the cable 1042 ispulled proximally, it would pull the sled 1022 distally. As notedearlier, alternative drivers, including, but not limited to a screwdrive, could be employed to pull or push the sled 1022. A rail 1044 isprovided to guide the travel of the sled in a lengthwise direction alongthe end effector and to help maintain alignment of the ramps 1030 and1034 with the driver heads 1024. The sled 1022 is further secured andguided by the roof and side wall of the end effector, which are notshown in FIGS. 41A-41B.

FIG. 41C is a schematic front view (looking toward the distal end of theend effector) showing the piercing member/suture driver 102 being drivenout of the end effector to its furthest extent by the driving action ofthe leading ramp 130 against the driver head 1024. FIG. 41D is aschematic rear view (looking toward the proximal end of the endeffector) showing the piercing member/suture driver 102 being retractedfully to the undeployed position in the end effector by the drivingaction of the trailing ramp 134 against the driver head 1024. FIG. 1022illustrates a top view of the distal end portion of FIG. 41A.

FIG. 42A illustrates an alternative embodiment of an individual drivermechanism in which the sled 1022′ rides over the top of the drive head1024′ and FIG. 42B illustrates the compact construction of thisembodiment as the sled 1022′ travels between the tissue clamps 106.

FIGS. 43A-43C illustrate arrangements and methods for installing arunning stitch using an attachment instrument according to variousembodiments of the present invention. A running stitch may be preferableto the interrupted stitches described thus far in regard to theattachment instruments above, in at least some situations, such as toprovide a second line of suturing (additional to a primary line ofsuturing that may be interrupted sutures or a running stitch) to preventherniation of a gastric plication. As described above, the instrumentscreate single stitches, which can be utilized as interrupted stitches.Each anchor mate 108 is molded or otherwise fixed to a suture, and eachanchor mate 108 is placed through the tissue desired to be stitched,into the anchor 106 on the other side of the tissue to create thestitch. A suture lock may be utilized to tighten and lock the suture inplace. Each individual or interrupted suture is created in this fashion.

In the embodiments of FIGS. 43A-43C, to create a running stitch, thefirst anchor mate 108 (leftmost anchor mate 108 in FIG. 43A, rightmostanchor mate 108 in FIGS. 43B-43C) on the distal end of the suture 104 isalso permanently fixed to the suture 104. The suture 104 then is loadedwith multiple anchor mates 108 bullets that are free to move along thelength of the suture 104 similar to beads on a string. The first anchormate 108 is placed through the tissue desired to be stitched into ananchor 108. This creates one anchoring point of the suture 104. Eachsubsequent anchor mate 108 is fired through the tissue into eachsubsequent anchor 106, respectively. This can be accomplished singularlyat the discretion of the physician, or can be preloaded in multiplesequence so that all the intended anchor mates 108 are fired in apredetermined configuration (i.e. predetermined number of anchor mates108, spacing between anchor mates 108, using straight suture drivers 102or curved suture drivers 102, etc.). Since the distal end of the suture104 is anchored by the fixed anchor mate 108/anchor 106 connection andeach subsequent anchor mate 108 allows the suture 104 to move freely,once all connections are made, the suture 104 can be pulled from theproximal end to tighten through a suture lock mechanism. The suture lockcan additionally or alternatively be incorporated into one or moresliding anchor mates 108 by creating locking teeth within the slidingring 108S of the anchor mate 108. The physician can control the tensionon the suture 104 as desired. FIG. 43B illustrate an arrangement whereall anchor mates 108 are driven through the tissues from the same sideof the tissues being joined. To create a more spiral shaped runningsuture the pattern of the anchor mates 108/anchors 106 can be alternatedfrom one side of the tissue to the other, as illustrated in FIG. 43C.

Referring back again to the embodiment of FIGS. 38A-38H, the suctionports 112 are annular, surrounding the suture anchors 106 and locatedbetween the suture anchors 106 and tissue contacting surface 1104 of endeffector 100E2′, as shown in the detailed view of FIG. 38B. Asillustrated in FIG. 38E, a clamp actuator feature 138A is provided foreach end effector (upper and lower) that is slidable by the operator ofinstrument 100′ to effect mechanical clamping and unclamping asdescribed in more detail below.

FIG. 38C illustrates the positions/orientations of clamping jaws 138Jrelative to the suture anchors 106, wherein a gap is maintainedtherebetween in which the suction ports 112 are located. It should benoted here, that although the clamping mechanism is descried here withparticularity with regard to the lower end effector, that the upper endeffector contains the same mechanism, except a stationary is provided tosurround each suture driver 102, through which suture driver 102 isslidable, and the stationary feature has tissue clamped against it inthe same way the tissue is clamped against the anchor 106 in the loweractuator. The clamp actuator 138 that is drivable by actuator feature138A is in an unclamped position in FIG. 38C. The cross-sectional viewin FIG. 38D taken along line 38D-38D of FIG. 38C better illustrates thegap between unclamped jaw 138J and suture anchor 106 that permits airflow and stomach tissue (drawn by suction applied via vacuum chambers112V).

With the secondary mechanical clamping non-actuated as shown in FIGS.38A-38D, stomach tissue is pulled into the gaps between the jaws 138Jand suture anchors 106 by application of suction through the suctionports 112. Upon advancing (sliding) the actuator feature 138A asillustrated in FIG. 38E, this drives the actuator 138 distally relativeto the end effector and drives the actuator lobes 138L into contactagainst clamping jaws 138J. This drives the clamping jaws 138J towardsthe suture anchor 106, thereby mechanically clamping stomach tissuesthat were drawn into the gaps, between jaws 138J and suture anchor 106,see FIG. 38F. FIG. 38G is a top view of FIG. 38F which more clearlyshows the clamping jaws 138J in the clamping position relative to thesuture anchor 106, such that tissues between these features would besecurely mechanically clamped.

FIG. 38H is a cross-sectional view of FIG. 38G taken along line 38H-38Hthat better shows the contact between the actuator lobes 138L andclamping jaws 138J, as well as showing the jaws 138J having been driventoward (and in this case in contact with, although that is not alwaysabsolutely necessary) suture anchor 106 in the clamping configuration.

This tissue clamping complements the engagement and grasping of thestomach 3 tissue by the suction system, and provides a stronger grip onthe stomach 3 tissue so that the instrument does not prematurely releaseits grip on the stomach 3 tissue. To release the secondary clamping, theoperator can pull the actuator 138 proximally so that the lobes 138L nolonger contact the clamping jaws 138J, like shown in FIG. 38A, whereuponthe clamping jaws 138J resiliently return to their unclamped positionsshown in FIG. 38C, thereby allowing tissue to be released upondeactivation of the suction.

FIGS. 39A-39 illustrate various events for the performance of aprocedure for decreasing the effective volume of a patient's stomachthat includes extragastric procedures on the stomach to create at leastone plication, according to another embodiment of the present invention.After establishing ports/pathway into the abdominal cavity from outsidethe patient, the omentum 5 and connective tissues are dissected at thegreater curve of the stomach to provide access thereto, the same asdescribed above with regard to FIGS. 7A-7B. A bougie 50, 50′, 50″, 50″′is inserted trans-esophageally and placed in the stomach 3 in a positionlike shown in FIG. 7C and the cross-sectional schematic representationsin FIGS. 39A-39K. Typically the bougie 50, 50′ 50″, 50″′ occupies apathway extending naturally from the esophagus, through the stomach 3and into the pylorus 3P, so as to occupy a space similar to what isdefined when a sleeve gastrectomy is performed. The bougie acts as aguide so as to better standardize the sizes and locations of plicationsformed by the procedure as well as to prevent reducing the stomach 3 tooaggressively, so as to ensure no blockage locations are inadvertentlyformed.

In the embodiments of FIGS. 39A-39K the functions of the instrumentsperforming the procedure are divided among at least two instruments.Engagement and manipulation of the stomach tissue are performed usingand engagement instrument 1200 or two or more laparoscopic grasperinstruments 1202, 1204 as described below. Engagement instrument 1200 isconfigured like instrument 200 or could be configured like instrument200′, but in each case, engagement is performed by graspers jaws 1206 orother clamping mechanism that are included in instrument 1200 instead ofthe suction ports of instrument 200, 200′. In the same manner theinstrument 200, 200′ or any other instrument described herein may employsuction ports in only one end effector, while providing the contactsurface of the opposite end effector with enhanced friction capability(e.g., by knurling, or providing some other surface treatment and/orcoating to increase friction), instrument 1200 may optionally beprovided with grasper jaws 1206 on only one of end effectors 1200E1 or1200E2, while providing the other end effector with a contact surfaceexhibiting enhanced friction, but without grasper jaws. In this optionalcase, as well as with engaging with a suction instrument having suctionon only one end effector, the procedures described can still be carriedout effectively, except for the optional rotation step like that shownin FIGS. 2F′, 5F′ and 39E′. Other features of instrument 1200, such asshaft, handle and optional shaft joint can be the same as or similar tothose of instruments 200, 200′ and others of those described above.Stitching instrument 1250 is configured like instrument 250 (or can beconfigured like 250′ when 1200 is configured like 200′) with thepiercing members/suture drivers 102, attachment members/sutures 104,anchors 106, anchor mates 108, suture locks 110 and actuation mechanismstherefore, but without suction ports 112 (although, optionally, suctionports may be included in the end effectors of instrument 1250) orconnection/joint mechanism. Also included are shaft 120, handle 114 and,optionally, suction line 116.

Engagement instrument 1200 is inserted into the abdominal cavity and aworking end thereof is positioned over locations on the stomach 3 wherea plication line is intended to be formed. The working end is the distalend portion of the instrument 1200 and includes a first end effector1200E1 and a second end effector 1200E2 (cross-sectional illustrationsof end effectors 1200E1 and 1200E2 are schematically represented inFIGS. 39C-39H) extending alongside and opposing first end effector200E1. One of the end effectors 1200E1, 1200E2 is placed on a posteriorsurface of the stomach 3 and the other is placed on an anterior surfaceof the stomach 3 along a line opposed to a line of the posterior surfacethat the first end effector contacts. In the embodiment shown in FIG.39C, end effector 1200E1 is contacted to the anterior surface, and endeffector 1200E2 is contacted to the posterior surface. Alternatively,end effector 1200E1 could be contacted to the posterior surface, and endeffector 1200E2 could be contacted to the anterior surface.

The operator of instrument 1200 then actuates end effectors 1200E1,1200E2 to engage the surfaces of the stomach 3 that they are contactedto with grasping jaws 1206 as illustrated in FIG. 39C. Alternative touse of instrument 1200, grasper instruments can be used to carry out thefunctions of instrument 1200. In this case, the working end (endeffector) 1202 of a first grasper is inserted into the abdominal cavityand positioned over locations on the stomach 3 where a plication line isintended to be formed, see FIG. 39A. The operator then actuates thegrasper to engage the surfaces of the stomach 3 that the grasping jawsof grasper distal end 1202 as illustrated in FIG. 39B. Optionally, butpreferably, the graspers include a locking feature that allows the userto lock the grasper jaws in the configuration shown in FIG. 39B.Alternatively, the grasping of the tissue may be performed with adifferent type of mechanism, such as providing 1206 as rollers thatrotate to pinch and grasp the tissue, or multiple small rotating needlesthat pierce into the tissue to grasp the tissue wall. The steps of FIGS.39A-39B are repeated with a second graspers instrument so that alocation on the stomach opposite the location where graspers (endeffector) 1202 grasps the stomach is grasped by the working end/endeffector 1204/grasper jaws 1206 of the second grasper instrument asillustrated in FIG. 39C. From FIG. 39C forward, the procedures conductedas described with reference to FIGS. 39C through 39H can be carried outusing instrument 1200 or, alternatively, two or more grasper instruments1202, 1204.

The working end of instrument 1200 is the distal end portion of theinstrument 1200 and includes a first end effector 1200E1 and a secondend effector 1200E2 (cross-sectional illustrations of end effectors1200E1 and 1200E2 are schematically represented in FIGS. 39C-39H)extending alongside and opposing first end effector 200E1. One of theend effectors 1200E1, 1200E2 is placed on a posterior surface of thestomach 3 and the other is placed on an anterior surface of the stomach3 along a line opposed to a line of the posterior surface that the firstend effector contacts. In the embodiment shown in FIG. 39C, end effector1200E1 is contacted to the anterior surface, and end effector 1200E2 iscontacted to the posterior surface. Alternatively, end effector 1200E1could be contacted to the posterior surface, and end effector 1200E2could be contacted to the anterior surface. Whether using instrument1200 or graspers 1202, 1204, the engagement forces are sufficientlystrong so that when the end effectors 1200E1, 1200E2 (or 1202, 1204) areseparated (moved away from one another) as illustrated in FIG. 39D, theportions of the stomach wall engaged by the end effectors are also drawnapart, thereby expanding the interior volume within the stomach 3. It isnoted here that separation of the end effectors 1200E1, 1200E2 orgraspers 1202, 1204 to expand the interior volume within the stomachdoes not require that both end effectors 1200E1 and 1200E2 be moved, orthat both graspers 1202 and 1204 be moved. Rather, only relativemovement between the two is required. Therefore, alternatively, endeffector 1200E1 can be moved while holding end effector 1200E2stationary or end effector 1200E2 can be moved while holding endeffector 1200E1 stationary. Likewise graspers instrument 1202 can bemoved while holding graspers instrument 1204 stationary or graspersinstrument 1204 can be moved while holding graspers instrument 1202stationary. Likewise, all other procedures described herein to separatethe stomach walls apart so as to increase the interior volume of thestomach can be performed by moving both of the engaged members apart, ormoving only one or the other of the engaged members away from the otherwhile holding the other stationary.

Next, a portion of the stomach forming at least a portion of the greatercurvature 3G is plicated, i.e., tucked, into the gap 1200G formed byseparating the end effectors 1200E1, 1200E2 (or 1202, 1204) asillustrated in FIG. 39E. The plicated portion of the stomach is foldedto an extent that it is located on the opposite side of the intendedplication line, relative to its pre-plicated location, as can beobserved by comparing FIG. 39D with FIG. 39E. Optionally, but only invariants in which both sides of the stomach are grasped in thisprocedural embodiment, prior to plicating the portion of the stomach,the operator of the instrument 1200 (or graspers 1202, 1204) may rotatethe instrument 1200 (or graspers, 1202, 1204 in concert) to rotate thestomach 3 by about ninety degrees (counterclockwise in the embodimentshown in optional step of FIG. 39E′). This option positions the stomachto allow gravity to assist in plicating the portion 3G through the gap1200G, making the plicating much easier as the portion 3G “falls” inthrough gap 1200G.

Once the portion 3G has been plicated appropriately according to eitheroptional technique described above, the instrument 1200/graspers 1202,1204 is/are then operated to rotate the grasping jaws 1206/end effectors1200E1, 1200E2/graspers 1202, 1204 and move them together, into contactwith one another, as illustrated in FIG. 39F. During this step, andthroughout the following steps, the instrument(s) and stomach 3 can bemaintained in the rotated orientation (as shown in FIG. 39E′) or can berotated back to the original orientation shown in FIG. 39F. The endeffectors 1200E1, 1200E2 or working ends 1202, 1204 of the graspers whenjoined as in FIG. 39F can optionally be provided with joining features1208, 1208′, respectively, to facilitate joining and or strengthen thejoint once it has been made. Such joining features may include one ormore of, but are not limited to: mating magnets, mating snap elements;mating hook and loop type fasteners, etc.

Next, the surgeon can use a standard laparoscopic needle driver andneedle with suture attached thereto, to suture the plication manually.Alternatively, instrument 1250 is mounted over the folded tissue layersof the plication so that third end effector 1250E1 and fourth endeffector 1250E2 are positioned on opposite sides of the tissues as shownin FIG. 39G. Instrument 1250 can be configured to fit in gaps in theinstrument 1200 (or between, distal to, or proximal of grasping jaws ofgraspers 1202, 1204) between sets of grasping jaws 1206. Although notshown in FIGS. 39G-39K, a layer of material 230 may optionally bemounted in instrument 1250, like shown and described with regard to FIG.5G, which wraps around from the operational surface of end effector1250E1 to the operational surface of end effector 1250E2 and overliesthe locations of the operational surfaces where the piercingmembers/suture drivers are driven out from, as well as the locationswhere the suture anchors are removably mounted. After mounting asdescribed, instrument 1250 is operated to attach the folded tissuesurfaces of the stomach together in serosa-to-serosa contact to hold theplication. At the same time the layer of material 230, when used, isattached to the plication. Material 230 forms a barrier layer that spansthe suture line to prevent herniation of the plicated stomach in betweenthe attachment members/sutures, thereby greatly reducing the risk ofischemia. The barrier material may be a sheet or strip of silicone, withor without mesh reinforcement, for example. Whether or not reinforced,the exterior of the strip is silicone, to prevent tissue ingrowth. Bypreventing tissue ingrowth, this will facilitate reversal of theprocedure/plication as the silicone strip will be easily removable.

At FIG. 39H piercing members/suture drivers 102 (preferably needles, butcould alternately be screw drives or other elongated members configuredto temporarily attach attachment members/sutures to and to drive throughthe stomach tissues) are deployed from end effector 1250E1 to driveattachment members/sutures 104 through stomach tissues (and material230, when used). Suture anchors 106 are removably held in end effector1250E2 and are aligned with the piercing members/suture drivers 102.Attachment members/sutures 104 are releasably engaged with piercingmembers/suture drivers 102. Upon withdrawal of the piercingmembers/suture drivers, the proximal ends of the suture mates 108P areretained by the anchors 106 and the suture mates 108 slide off thepiercing members/suture drivers 102, thereby leaving the suture mates108 and attachment members/sutures 104 installed through the tissues(and, optionally, material 230) as illustrated in FIG. 39I. It is notedhere that if the optional rotation is performed in FIG. 39E′, then theinstrument(s) is/are counter-rotated to return the stomach 3 to theorientation shown in FIG. 39F, 39G, 39H, or 39I, after performing theprocedures described above with regard to FIG. 39E′ or after performingthe procedures described above with regard to FIG. 39F, or afterperforming the procedures described above with regard to FIG. 39G, orafter performing the procedures described above with regard to FIG. 39H.

Attachment members/sutures 104 are also pre-installed through suturelocks 110 that are removably mounted on end effector 1250E1 and aremounted on attachment members/sutures 104 proximal to the piercingmembers/suture drivers 102. Once the attachment members/sutures havebeen driven and anchored as illustrated in FIG. 39HI and the stomach 3has been rotated back to its original orientation, if applicable,instruments 1250 and 1200/1202,1204 are removed from the patient,leaving the attachment members/sutures 104, suture locks 110,(optionally, material 230) suture anchors 106 and suture anchor mates108 in place as illustrated in FIG. 39I. Suture locks 110 have a one-waylocking mechanism, such as a ratcheting type mechanism or otherarrangement such as directionally oriented teeth that allow suture 104to be pulled proximally therethrough, but which prevent attachmentmembers/sutures 104 from backsliding distally therethrough. At FIG. 39J,the attachment members/sutures 104 are cinched by pulling themproximally relative to the suture locks 110 until a desired amount oftension is developed in the attachment members/sutures 104, as describedpreviously. Cinching can be performed by the use of laparoscopicgraspers, for example. The bougie 50,50′,50″,50″′ can then be removedfrom the patient and the patient can be closed, according to knowntechniques, to complete the procedure.

As a further option, an expandable implant 10 may be implanted to fillthe inside of the plication 3PL as illustrated in FIG. 39K. The implant10 may be a silicone bladder, for example, capable of being inflated bybiocompatible fluid such as liquid, gas, or a combination of fluids(gases, liquids, or liquids and gases). Implant 10 is connected via filltubing 12 in fluid communication with a subcutaneous fill port 80, sothat the fill volume of implant 10 can be adjusted after implanting itas described from a location outside of the abdominal cavity (e.g., byan operator accessing the subcutaneous fill port 80 with a needle aloneor a needle attached to a pressurized source of fluid). Other implants10 may be substituted, but need to be expandable and are preferablycontrollable as to amount of expansion. A tab or wing 11, 11′, 11″, 11″′may be provided to extend from the expandable body of the implant 10 andcan be inserted between the tissue folds at the plication suture line sothat the attachment members/sutures 104 are also installed through thetab or wing 11, 11′, 11″, 11″′ to thereby securely hold the implant inplace, as illustrated in FIG. 39K. The tab or wing 11, 11′, 11″, 11″′may be made of a mesh-reinforced silicone, for example. Alternatively,the implant 10 may be fixed in place by connecting only to the superiorand inferior ends of the plication suture line, or by connecting to oneor more of the suture locks 110 and/or suture anchors 106.

FIG. 44A illustrates a perspective view embodiment of a handle portionof an instrument capable of operating end effectors designed accordingto certain aspects of the invention. Handle 1830 is in fluidcommunication with suction line 116 to provide a connection fromsuctions ports in the end effectors connected to handle 1830 and asource of negative pressure. Handle 1830 includes actuators 1832 and1832′, which are configured to operate the clamping action of the endeffectors. Handle 1830 further include locking actuator 1838 which isconfigured to reversibly lock the end effectors in place and allow theuser to release actuators 1832 and 1832′ while maintaining the degree ofclamping of the end effectors. Handle 1830 further includes suctionactuator 1836, which is configured to reduce the amount of suctionapplied to the end effectors. Suction actuator 1836 can be slid orotherwise moved from a first position, corresponding to a full suction,to a second position, corresponding to no suction. Suction actuator 1836can maintain positions between the first position and the secondposition to provide intermediate amounts of suction.

FIG. 44B illustrates a cross-sectional view of handle 1830. Actuators1832 and 1832′ are depicted as each being connected via a rod assemblyto traveller 1870, although other mechanical connections betweenactuators 1832 and 1832′ and traveller 1870 are contemplated as withinthe scope of these embodiments. According to the embodiment in FIG. 44B,squeezing one or both of actuators 1832 and 1832′ towards suction line116 moves traveller 1870 proximally within handle 1830. Actuators 1832and 1832′ can be biased in an open position using a spring or a similarmechanism. Alternatively or additionally, traveller 1870 may be biasedto in a distal position with handle 1830 using a spring or similarmechanism. Traveller 1870 is connected to pulley 1860 and pulley 1860moves proximally with traveller 1870 when actuators 1832 and 1832′ causesuch proximal movement. Pulley 1860 is engaged with cables (notpictured), which in turn are engaged with end effectors. According tocertain embodiments, cables (or a cable) are looped around pulley 1860such that the cable or cables can move circumferentially with respect topulley 1860. An advantage of the cable or cables being looped aroundpulley 1860, rather than fixed to pulley 1860, is that the end-effectorsare capable of self-adjusting to the varying thickness of the tissueclamped between them. Locking actuator 1838 is configured to engagetraveller 1870 and reversibly lock traveller 1870 in a fixed position.In certain embodiments, locking actuator 1838 includes teeth on aproximal portion and these teeth can engage similar teeth on traveller1870. Locking actuator 1838 is configured to pivot about a pivot pointto reversibly engage the teeth of the actuator with the teeth of thetraveller to provide the reversible locking function. It is understoodthat other mechanisms for engaging locking actuator 1838 and traveller1870 are contemplated as within the scope of the invention. Handle 1830further includes suction actuator 1836, which is configured to reducethe amount of suction applied to the end effectors. Suction actuator1836 can be configured to actuate many types of valves capable of beingplaced the instrument, including butterfly valves, ball valves, togglevalves, and the like.

FIG. 45A illustrates a cross-sectional view of a clamping mechanism foruse with end effectors according to certain embodiments of theinvention. FIG. 45A depicts the proximal portions of end effectors 2100and 2100′. In certain aspects of the invention, it may be desirable tomaintain a substantially parallel relationship between end effectorsduring clamping of tissue. The mechanism in FIG. 45A providessubstantially uniform clamping through the use of pairs of slidable arms2110 and 2110′ connected with pivoting arms 2115 and 2115′. Arms 2110,2110′, 2115, and 2115′ may be straight or they may include an angle orcurve. Arms 2110, 2110′, 2115, and 2115′ are pivotally connected to endeffectors 2100 and 2100′. Slidable arms 2110 and 2110′ are slidablymounted to sliding rail 2170. Fixed arms 2115 and 2115′ are alsoconnected to sliding rail 2170 and are configured to provide a clampingforce when sliding rail 2170 is advanced distally. Sliding rail 2170 canbe advanced distally via a push rod, screw drive, or similar mechanismconfigured to be actuated by a handle according to embodiments of theinvention. Lower arms 2120 and 2120′ include stops that mate withsliding rail 2170 as sliding rail 2170 is moved proximally to reopen endeffectors 2100 and 2100′. Advantageously, the arms and sliding rail ofthis embodiment are configures to provide a substantially parallelclamping mechanism.

FIG. 45B illustrates a view of a clamping mechanism and end effectorsaccording to certain embodiments. End effectors 2100 and 2100′ areconnected near their proximal and distal end by scissor-type mechanisms.The scissor-type mechanisms include sliding arm 2152, which isconfigured to slide within recess 2150. Sliding arm 2152 is connected topivoting arm 2154, which has one and fixed within recess 2150. Slidingarm 2152 is also connected to push rod 2180, which has a push rod distalportion 2180D and a push rod proximal portion 2180P. When push rod 2180is pulled proximally, sliding arm 2152 slides within recess 2150 andactuates the clamping of end effectors 2100 and 2100′. The proximalportions of end effectors 2100 and 2100′ include sliding arm 2152′,pivoting arm 2154′, and recess 2150′, which function to actuate theclamping of end effectors 2100 and 2100′ in a similar manner.

FIG. 45C illustrates a view of another clamping mechanism according tocertain embodiments. End effectors 2100 and 2100′ are illustrated asbeing connected by a screw-type drive. Threaded nut 2190 is fixed withinend effector 2100 such that a threaded rod traveling into cavity 2195draws end effector 2100′ toward end effector 2100. The threaded rod orthe threaded nut can be actuated from the handle portion of theinstrument to facilitate clamping using such a screw-type mechanism.

FIG. 46A illustrates a view of an end effector assembly according tocertain embodiments. End effectors 3100 and 3100′ are connected throughtelescoping connectors 3150 and 3150′. In certain embodiments,telescoping connectors include lumens through which negative pressurecan be applied to the end effectors and their suction ports. FIG. 46Billustrates a cross-sectional view of end effectors 3100 and 3100′ andtelescoping connector 3150′. Telescoping connector 3150′ includes aseries of nested connecting tubes 3152, 3154, 3154′, 3156, and 3156′.These nested connecting tubes have lumens for providing suction, andnest in series to provide telescoping action. The nested connectingtubes have flanged ends which sealingly connect with the adjacent tube.The flanged ends are held within the adjacent tube via a lip on theinternal diameter of the adjacent tube. This arrangement of flanges andlips limits the loss of suction flow through the telescoping connector3150′. Although FIG. 46B depicts five nested tubes it is understood thatmore or fewer tubes may be used to form telescoping connector 3150′.Telescoping connector 3150′ may be biased in an extended position byplacing a spring within the lumens of the nested connectors to holdeffectors 3100 and 3100′ apart. Other biasing mechanisms may also beused. Further, telescoping connector 3150′ may be biased closed vianegative pressure applied to the instrument and may assume an extendedposition by being actuated from the handle using mechanisms describedherein such as cables, rods, screw drives, and the like. In certainembodiments, a cable runs along the central axis of telescopingconnector 3150′ and can be used to limit the extension of telescopingconnector 3150′ and/or to provide compression of telescoping connector3150′ into a compressed position. While not pictured, telescopingconnector 3150 is understood to be configured according to any of theways described for telescoping connector 3150′. Advantageously,telescoping connectors 3150 and 3150′ nest together with flat sides. Theflat sides help maintain a parallel relationship between end effectors3100 and 3100′ and help prevent torqueing and twisting of one endeffector relative to the other during clamping and release of tissue.

FIG. 46C illustrates a view of a distal portion of an end effectorassembly according to certain embodiments. Effectors 3100 and 3100′ areconnected via bellows 3180, which has a corrugated configuration capableof being compressed. Bellows 3180 has a central lumen through whichnegative pressure may flow to provide suction to end effectors 3100 and3100′ and their suction ports. Spring 3185 biases bellows 3180 into anextended position. End effectors 3100 and 3100′ can be clamped togetherusing suction or any of the mechanical means described herein. Thecombination of bellows 3180 and spring 3185 provides desirable fluidcommunication between end effectors 3100 and 3100′ as well as desirablemechanical separation between and effectors 3100 and 3100′.

FIGS. 46D and 46E illustrate an alternative embodiment of bellows 3180in which bellows 3180 has a horn-type shape. Bellows 3180 is made from aresilient material such as an elastomer and is configured topreferentially fold or collapse under mechanical force or under theforce provided by suction. The resilient characteristic of bellows 3180enables it to return to its initial shape when such force is removed.FIG. 46D depicts bellows 3180 in its initial shape and FIG. 46E depictsbellows 3180 in a collapsed shape.

FIG. 46F illustrates an alternative embodiment of bellows 3180 in whichbellows 3180 connects end effectors 3100 and 3100′ but is not positionedbetween them. In certain embodiments, bellows 3180 connects and providesfluid communication between end effectors 3100 and 3100′ but is notpositioned between them. FIG. 46F depicts bellows 3180 as a tube havinga lumen through which negative pressure may flow. Spring 3185 helpsprevent bellows 3180 from collapsing under negative pressure and mayalso provide a spring force to bias end effectors 3100 and 3100′ apart.End effectors 3100 and 3100′ can be clamped and separated using themechanical means described herein.

FIG. 47A illustrates a perspective view of an end effector according tocertain embodiments. End effector 3100 includes lumen 3500 through whichsuction may be applied to suction ports 112. Suction ports 112 arepositioned on end effector 3100 along the edge between the tissue-facingclamping surface and outer surface of the end effector 3100. Vacuumchannels 3510 provide fluid communication between suction ports 112 andlumen 3500. Vacuum channels 3510 allow negative pressure airflow to betransmitted along a surface within suction ports 112. Vacuum channels3150 are sufficiently narrow to prevent the tissue held by the negativepressure from blocking the airflow. This is desirable because blockingairflow may lead to a loss of suction in the system and detachment ofthe tissue from the clamping surface. FIG. 47B illustrates cross-sectionof an end effector according to certain embodiments. Lumen 3500 is influid communication with cavity 3550 via constrictor 3560 and optionallyvia vacuum channels, which are not pictured in FIG. 47B as it is across-section taken down the channel portion of a vacuum channel.Constrictor 3560 limits the volume of air flowing through an uncoveredsuction port 112. This serves to preserve vacuum pressure in the lumen.In certain embodiments, a mesh may be placed over the vacuum channels toprevent tissue from pulling into the channels. Such a mesh may be madefrom plastic or metal or other suitable materials. Advantageously, themesh may be fabricated separately from the end effector allowing themesh to be replaced or customized in end effectors.

FIG. 47C illustrates cross-section of an end effector interacting withstomach tissue according to certain embodiments. Stomach 3 is depictedas having been pulled into the cavity of a suction port of an endeffector. Stomach 3 is pulled against mesh 3600, which excludes stomach3 from being pulled into channel 3525. Mesh 3600 meets upper slot lip3574 at corner 3530. Preferably, mesh 3600 includes one or more largeropenings at corner 3530 to maintain suction against the stomach tissuewithin the cavity of the suction port. Vacuum at corner 3530 pullsstomach 3 into corner 3530 and combines with the protruding edge on theupper slot lip 3574 to form the stomach into a concave curve againstlower slot lip 3572. This concave curve forms a vacuum seal againstlower slot lip 3572 that cannot be broken without first pulling stomach3 away from the vacuum channel. The increased work required to pull thestomach away from the vacuum channels improves the hold resilience ofthe slot and provides a physical barrier to the escape of the stomach.Advantageously, the force required to detach the stomach tissue from thesuction port of this embodiment is higher than the force required tosimply peel stomach tissue from ports formed on the tissue-facingclamping surface of an end effector.

FIG. 47D illustrates a perspective view of a mesh according to certainembodiments. Mesh 3600 is configured in this embodiment as a moldeddiffuser having a plurality of circular holes. Without being bound to aparticular theory or mechanism of action, it is believed that circularholes are preferred over elongated holes to exclude stomach tissue frombeing sucked into a cavity. It is believed that stomach tissue iscapable of folding and entering elongated slots, but is less capable ofstretching to enter circular holes. The holes of mesh 3600 arepreferably about 0.010″ in diameter, and such hole size can help preventdamage to tissue by excluding it from being folded, crumpled, orotherwise strained within small cavities of an end effector. FIG. 47Ddepicts the holes present at corner 3530 when mesh is placed within asuction port of an end effector such as that illustrated in FIG. 47C.FIG. 47D depicts a further useful feature of mesh 3600 in that the holespresent at corner 3530 are displaced deeper in the vacuum channel thanthe holes at the major surface of mesh 3600. The extra depth provided bydisplacing the holes present at corner 3530 increases the surface areaof the concave curve against upper slot lip 3574 when mesh is placedwithin a suction port of an end effector such as that illustrated inFIG. 47C. This greater surface area of the concave curve furtherincreases the work required to pull the stomach away from the vacuumchannels and further improves the hold resilience of the slot andprovides a physical barrier to the escape of the stomach.

FIG. 47E illustrates an alternative embodiment of a suction slot andchannel system for an end effector. FIG. 47E depicts lumen 3500 as beingin fluid connection with cavity 3550 and slot 112. In this embodiment,the slot and channel system is configured to provide slot lips 3574 and3574′, which are each proximate to an opening to lumen 3500 or cavity3550, respectively. The openings near slot lips 3574 and 3574′ provide asimilar force as described above to form concave curves of stomachtissue within the interior of slot 112. Such concave curves increase thework required to pull the stomach away from the vacuum channels andimprove the hold resilience of the slot and provide a physical barrierto the escape of the stomach.

FIG. 47F illustrates a cross-section of an alternative suction port foruse in an end effector according to certain embodiments. FIG. 47Fdepicts suction port 112 with a flexible suction cup 3800 positioned onthe tissue-facing side of suction port 112. Suction cup 3800 include athin flexible edge, like those used in larger industrial applications topickup bags of products on automated assembly lines (e.g., bags ofpotato chips). A very flexible suction cup edge has the advantage thatit can move with the tension of the tissue and maintain a seal to avoidallowing leak paths to start which maintains suction better. This thinedge feature is helpful with tissue because while most suction cupsattach onto a flat surface (like a window or mirror), stomach tissue canwrinkle, fold, and pull away in a manner that forms leak paths with mostrigid suction cups.

FIG. 47G illustrates a cross-section of an alternative suction port foruse in an end effector according to certain embodiments. Suction port112 includes suction cup 3800, which in this embodiments is configuredto fold into cavity 3550 when suction forces pull tissue into cavity3550. Suction cup 3800 is formed from a resilient material, such as anelastomer. By folding inward, suction cup 3800 acts to trap stomachtissue within cavity 3550 and present a physical barrier to the escapeof stomach tissue in the event that the suction force becomesdiminished. Suction cup 3800 may contain features that reversiblycrumple under the force of stomach tissue being sucked into cavity 3550and such feature similarly form a trap for the captured tissue byproviding a physical barrier to tissue escape. Further, it iscontemplated that FIG. 47G depicts an insert to be placed with in thecavity of a suction port. In this embodiment, the insert is flexible andresilient, acts to trap stomach tissue as described above, and isreplaceable and customizable.

FIG. 47H illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. Suction cup3800 is configured to resemble a grate with elongated slots, which slotsallow stomach tissue to fold within them and enter the suction port. Inits initial state, suction cup 3800 has a convex configuration withrespect to the tissue-facing clamping surface and protrudes outwardtoward stomach tissue from such tissue-facing surface. Suction cup 3800is formed from compliant, flexible, and resilient materials such thatunder the force of tissue being sucked into the suction port, suctioncup 3800 inverts into a concave configuration and clamps stomach tissuesecurely in place. Suction cup 3800 thereby provides an additionalphysical barrier to the escape of stomach tissue.

FIG. 47I illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. Suction cup3800 is configured to include one or more fingers, which protrude intothe opening of the suction port. Suction cup 3800 is formed fromcompliant, flexible, and resilient materials such that under the forceof tissue being sucked into the suction port, the fingers of suction cup3800 fold inward and clamp stomach tissue securely in place. Suction cup3800 thereby provides an additional physical barrier to the escape ofstomach tissue.

FIG. 47J illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. The suctionport includes clips 3850 and 3850′, which are formed from a resilientmaterial. Under the force of stomach tissue being sucked into thesuction port, clips 3850 and 3850′ deflect to engage and capture foldsof stomach tissue. Clips 3850 and 3850′ thereby provides an additionalphysical barrier to the escape of stomach tissue.

FIG. 47K illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. Suctionport 112 includes pleated interior features, which increase the surfacearea of stomach tissue captured within the suction port and preventsuction from being blocked off by maintaining areas of air flow betweencertain areas of stomach tissue and the recessed surfaces of suctionport 112.

FIG. 47L illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. Suctionport 112 is configured to have a comparatively small inlet and standofffeatures to hold tissue away from inlet. The small inlet allows thepressure to build up and create suction when tissue is present, but iftissue pulls away, the small inlet limits the loss of suction ascompared to a larger inlet. The standoffs hold the tissue away toprevent clogging into the small inlet, and instead hold the tissue wherea larger diameter of the suction cup engages the tissue.

FIG. 47M illustrates a perspective view of an alternative suction portfor use in an end effector according to certain embodiments. Suctionport 112 is configured to have one or more ribs to hold tissue away fromthe suction inlet. Similar to the standoffs described herein, the ribshold the tissue away to prevent clogging into the small inlet, andinstead hold the tissue where a larger portion of the suction cupengages the tissue.

FIG. 47N illustrates a perspective view of another alternative suctionport for use in an end effector according to certain embodiments.Suction port 112 is configured to have concentric ribs to hold tissueaway from the suction inlet. Similar to the standoffs described herein,the ribs hold the tissue away to prevent clogging into the small inlet,and instead hold the tissue where a larger portion of the suction cupengages the tissue.

FIGS. 48A and 48B illustrate perspective views of a modular system ofend effectors and suction ports. End effector 4100 includes elongatemanifold 4110, which has cutouts configured to accept modular suctionports 4150. This modular design enables comparatively fast and easyassembly of an end effector with few parts. Suction ports 4150 plug intoand clips onto elongate manifold 4110. Suction ports 4150 can includetapered nipples to help ensure a good seal between the openings of theelongate manifold 4110 and the ports.

FIGS. 49A and 49B illustrate perspective views of the function of astomach tissue engagement system. FIGS. 48A and 49B depict an alternateembodiment from that depicted in FIGS. 37A-37C herein. In thisembodiment, actuator 138 is drawn proximally relative to the system,which brings lobes 138L into contact with stomach tissue that has beendrawn into slots 112. To release this secondary clamping, actuator 138can be moved distally. This tissue clamping complements the engagementand grasping of the stomach 3 tissue by the suction system, and providesa stronger grip on the stomach 3 tissue so that the instrument does notprematurely release its grip on the stomach 3 tissue.

In certain embodiments, the Bernoulli Effect is used to create vacuum ateach individual suction port. In such embodiments, compressed gas isdirected to the end effecters via tubing. The end effecters aresubstantially hollow with several openings or ports where suction isdesired. Immediately adjacent to each suction port in the hollow portionof the end effector is a small venturi or narrowing which increases theflow velocity locally. According to the Bernoulli Effect, a vacuum iscreated at the point where the flow becomes narrow. This narrowestportion is connected to the suction port. The advantage of this approachis that the vacuum ports function independently so if one port is open,the others can still pull vacuum. For the embodiments described herein,a source of negative pressure includes suction created by employing theBernoulli Effect.

While the present invention has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. For example, an instrument as described herein may employsuction on one end effector to engage tissue, while providing graspingjaws on an opposite end effector to engage tissue or vice versa. Inaddition, many modifications may be made to adapt a particularsituation, material, composition of matter, process, process step orsteps, to the objective, spirit and scope of the present invention. Allsuch modifications are intended to be within the scope of the claimsappended hereto.

That which is claimed is:
 1. An instrument for use in modifying apatient's stomach by operating on the stomach extragastrically todecrease the effective volume of the patient's stomach, said instrumentcomprising: a first elongate end effector formed at a distal end portionof said instrument, said first elongate end effector having a firstoperational surface configured to contact an external surface of thepatient's stomach; a first plurality of suction ports extending along alength of said first elongate end effector and configured to deliversuction to the external surface of the stomach to engage said firstelongate end effector therewith, at least one suction port comprising ameans for providing a physical barrier to the escape of a portion of thestomach from the suction port a second elongate end effector; and aconnector in fluid communication with the first elongate end effectorand the second elongate end effector; wherein the connector comprisestelescoping segments.
 2. The instrument of claim 1 wherein the means forproviding a physical barrier to the escape of the stomach from thesuction port comprises at least one suction hole configured to hold thestomach against an interior surface of a lip of the suction port.
 3. Theinstrument of claim 2 wherein the at least one suction hole isconfigured within a cavity of the suction port to create a concave curvein a portion of the stomach near the interior surface of a lip of thesuction port.
 4. The instrument of claim 2 wherein the suction portcomprises at least one vacuum channel.
 5. The instrument of claim 2wherein the suction port comprises a tissue excluder configured toexclude the stomach from the at least one vacuum channel.
 6. Theinstrument of claim 1 wherein the means for providing a physical barrierto the escape of the stomach from the suction port comprises a resilientmember configured to deflect as suction is delivered to the externalsurface of the stomach.
 7. The instrument of claim 6 wherein theresilient member is configured to extend from the first operationalsurface toward the external surface of the stomach.
 8. The instrument ofclaim 6 wherein the resilient member comprises at least one slot.
 9. Theinstrument of claim 6 wherein the resilient member is configured toextend parallel to an opening of the suction port.
 10. The instrument ofclaim 6 wherein the resilient member is configured to extend from aninterior surface of the suction port.
 11. The instrument of claim 1further comprising: the second elongate end effector formed at a distalend portion of said instrument, said second elongate end effector havinga second operational surface configured to contact an external surfaceof the patient's stomach; a second plurality of suction ports extendingalong a length of said second elongate end effector and configured todeliver suction to the external surface of the stomach to engage saidsecond elongate end effector therewith, at least one suction portcomprising a means for providing a physical barrier to the escape of thestomach from the suction port.
 12. The instrument of claim 1 wherein theconnector is biased to hold the first elongate end effector and thesecond elongate end effector apart from each other.
 13. The instrumentof claim 1 wherein the connector is biased to hold the first elongateend effector and the second elongate end effector together.
 14. Aninstrument for use in modifying a patient's stomach by operating on thestomach extragastrically to decrease the effective volume of thepatient's stomach, said instrument comprising: at least two elongate endeffectors formed at a distal end portion of said instrument; a pluralityof suction ports extending along a length of each elongate end effector;a resilient and flexible member proximate at least one suction port'wherein the member is configured to provide a physical barrier to theescape of a portion of the stomach from the suction port; and aconnector in fluid communication with the each of the at least twoelongate end effectors; wherein the connector comprises telescopingsegments.
 15. The instrument of claim 14 wherein at least a portion ofthe member is within the suction port.
 16. The instrument of claim 14wherein the member is entirely within the suction port.
 17. Theinstrument of claim 14 wherein the member is outside the suction port.18. An instrument for use in modifying a patient's stomach by operatingon the stomach extragastrically to decrease the effective volume of thepatient's stomach, said instrument comprising: at least two elongate endeffectors formed at a distal end portion of said instrument; a pluralityof suction ports extending along a length of each elongate end effectorand configured to deliver suction to the external surface of the stomachto engage each end effector therewith, wherein at least one portcomprises an interior lip configured to maintain contact with thestomach when a portion of the stomach is within the suction port; and aconnector in fluid communication with each of the at least two elongateend effectors; wherein the connector comprises telescoping segments. 19.The instrument of claim 18 wherein the suction port comprises channels.20. The instrument of claim 18 wherein the suction port comprises atissue excluder.
 21. The instrument of claim 18 wherein the suction portcomprises a suction hole proximate the interior lip.